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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT00853112
Description:
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00853112
Study Brief:
A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension
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 | Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1. | None | None | 2 | 6 | 2 | 6 | View |
| PF-00489791 1 mg | Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. | None | None | 0 | 6 | 4 | 6 | View |
| PF-00489791 2 mg | Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. | None | None | 0 | 7 | 2 | 7 | View |
| PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. | None | None | 0 | 6 | 5 | 6 | View |
| PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. | None | None | 0 | 6 | 4 | 6 | View |
| PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. | None | None | 1 | 7 | 2 | 7 | View |
| Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. | None | None | 0 | 6 | 3 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v13.0 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v13.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v13.0 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v13.0 | View |
| Vulval cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v13.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eosinophilia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v13.0 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v13.0 | View |
| Ventricular extrasystoles | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v13.0 | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v13.0 | View |
| Ocular hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v13.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v13.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v13.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v13.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v13.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v13.0 | View |
| Axillary pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v13.0 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v13.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v13.0 | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v13.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v13.0 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v13.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v13.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v13.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v13.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v13.0 | View |
| Bacterial test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v13.0 | View |
| Bilirubin conjugated increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v13.0 | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v13.0 | View |
| Blood bilirubin unconjugated increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v13.0 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v13.0 | View |
| Blood glucose increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v13.0 | View |
| Blood urea increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v13.0 | View |
| Blood uric acid increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v13.0 | View |
| Electrocardiogram QT prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v13.0 | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v13.0 | View |
| Oxygen saturation decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v13.0 | View |
| Urinary sediment present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v13.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v13.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v13.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v13.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v13.0 | View |
| Tension headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v13.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v13.0 | View |
| Sleep disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v13.0 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v13.0 | View |
| Tachypnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v13.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v13.0 | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v13.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v13.0 | View |