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 @ 10:37 AM
Ignite Modification Date:
2025-12-26 @ 10:37 AM
NCT ID:
NCT01854528
Description:
AEs were collected from first dose to 30 days after last dose (16 weeks for 12-week treatment, 28 weeks for 24-week treatment, 52 weeks for 48-week treatment); SAEs were collected from the time that informed consent was obtained to end of study (up to 65 weeks for 12-week treatment, 77 weeks for 24-week treatment, 101 weeks for 48-week treatment).
Frequency Threshold:
5
Time Frame:
AEs were collected from the time of study drug administration to 30 days after last dose of study drug (up to 52 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (total up to 101 weeks).
Study:
NCT01854528
Study Brief:
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 3-DAA/RBV | 3-DAA (ABT-450/r/ABT-267 \[150 mg/ 100 mg/ 25 mg once daily\] and ABT-333 \[250 mg twice daily\]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. | None | None | 1 | 101 | 54 | 101 | View |
| TPV/RBV | TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously \[SC\] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information. | None | None | 5 | 47 | 43 | 47 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 17.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| INJECTION SITE PHLEBITIS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| DIARRHOEA INFECTIOUS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| STAPHYLOCOCCAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| EPILEPSY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| ECZEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 17.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 17.0 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 17.0 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 17.0 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 17.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| ANAL PRURITUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| APHTHOUS STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| HAEMORRHOIDS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| INFLUENZA LIKE ILLNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| INJECTION SITE ERYTHEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 17.0 | View |
| HYPERTRIGLYCERIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 17.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| LETHARGY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| DEPRESSED MOOD | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 17.0 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 17.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 17.0 | View |
| IRRITABILITY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 17.0 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 17.0 | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 17.0 | View |
| ECZEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 17.0 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 17.0 | View |
| PRURITUS GENERALISED | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 17.0 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 17.0 | View |