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 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
NCT ID:
NCT01432535
Description:
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01432535
Study Brief:
Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Healthy Participants | Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. | None | None | 0 | 12 | 12 | 12 | View |
| Participants With Moderate Renal Impairment | Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. | None | None | 0 | 7 | 7 | 7 | View |
| Participants With Severe Renal Impairment | Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. | None | None | 1 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Lymph node palpable | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Hypogeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Thirst | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |