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 @ 7:39 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
NCT ID:
NCT01425203
Description:
Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.
Frequency Threshold:
5
Time Frame:
RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks.
Study:
NCT01425203
Study Brief:
The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| PBO + PR (Control) | Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks. | None | None | 9 | 78 | 71 | 78 | View |
| Crossover Arm | Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8. | None | None | 1 | 27 | 22 | 27 | View |
| RGT BOC + PR | Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks. | None | None | 17 | 159 | 153 | 159 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Adverse event | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Osteomyelitis chronic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Accidental overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 16.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Hyperthermia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Body temperature increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |