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 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT02618928
Description:
None
Frequency Threshold:
5
Time Frame:
Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
Study:
NCT02618928
Study Brief:
The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir Without RBV | Participants received paritaprevir/ritonavir and ombitasvir without ribavirin for either 12 weeks. | 0 | None | 0 | 4 | 1 | 4 | View |
| Paritaprevir/Ritonavir + Ombitasvir With RBV | Participants received paritaprevir/ritonavir and ombitasvir with ribavirin for either 12 weeks. | 5 | None | 1 | 209 | 33 | 209 | View |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 8 or 12 weeks. | 1 | None | 13 | 429 | 38 | 429 | View |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks. | 2 | None | 6 | 86 | 11 | 86 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Versions 21.0 | View |
| CARDIAC FAILURE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Versions 21.0 | View |
| MYOCARDIAL INFARCTION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Versions 21.0 | View |
| INTESTINAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Versions 21.0 | View |
| OESOPHAGEAL VARICES HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Versions 21.0 | View |
| PANCREATITIS ACUTE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Versions 21.0 | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Versions 21.0 | View |
| HEPATOTOXICITY | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Versions 21.0 | View |
| APPENDICITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Versions 21.0 | View |
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Versions 21.0 | View |
| ANKLE FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Versions 21.0 | View |
| JOINT DISLOCATION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Versions 21.0 | View |
| PROTHROMBIN TIME PROLONGED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Versions 21.0 | View |
| DEHYDRATION | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Versions 21.0 | View |
| FOOD INTOLERANCE | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Versions 21.0 | View |
| HEPATIC CANCER | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Versions 21.0 | View |
| CAROTID ANEURYSM RUPTURE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Versions 21.0 | View |
| CEREBROVASCULAR ACCIDENT | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Versions 21.0 | View |
| ACUTE PSYCHOSIS | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Versions 21.0 | View |
| HYPOMANIA | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Versions 21.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Versions 21.0 | View |
| PRURITUS GENERALISED | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Versions 21.0 | View |
| ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Versions 21.0 | View |
| ASTHENIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Versions 21.0 | View |