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 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
NCT ID:
NCT04652804
Description:
All AEs that occurred after the entry visit and up to SVR evaluation were recorded if any of the following criteria were met:
* All grade ≥ 3 AEs
* All AEs that led to a change in treatment/intervention regardless of grade
* All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
Frequency Threshold:
0
Time Frame:
From date of randomization up to the expected Sustained Virologic Response (SVR) 12 week visit date
Study:
NCT04652804
Study Brief:
Supporting Treatment Outcomes Among PWID
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm 1: Low Intensity Intervention (Minimal Risk) | 4 weeks dispensation + standard adherence counseling Low intensity HCV treatment adherence support: A 28-day supply of medication will be dispensed to participants at entry, 4 weeks, and 8 weeks. Participants will receive standard adherence counseling at entry and every refill pickup/home or field delivery. Participants will have access to all of the services available at the ICC including facilitated linkage to referrals as needed. Site staff will routinely track clients who miss refill appointments in real-time using standard tracking measurements | 9 | None | 14 | 1022 | 1 | 1022 | View |
| Arm 2: Medium Intensity Intervention (Minimal Risk) | 4 weeks dispensation + support from patient navigator Medium intensity HCV treatment adherence support: The medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks. | 3 | None | 5 | 684 | 1 | 684 | View |
| Arm 3: High Intensity Intervention (Minimal Risk) | Directly Observed Therapy with flexible dispensing and support from patient navigator High intensity HCV treatment adherence support: The high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed. | 3 | None | 4 | 342 | 2 | 342 | View |
| Arm 1: Low Intensity Intervention (Elevated Risk) | 4 weeks dispensation + standard adherence counseling Low intensity HCV treatment adherence support: A 28-day supply of medication will be dispensed to participants at entry, 4 weeks, and 8 weeks. Participants will receive standard adherence counseling at entry and every refill pickup/home or field delivery. Participants will have access to all of the services available at the ICC including facilitated linkage to referrals as needed. Site staff will routinely track clients who miss refill appointments in real-time using standard tracking measurements | 4 | None | 7 | 157 | 1 | 157 | View |
| Arm 2: Medium Intensity Intervention (Elevated Risk) | 4 weeks dispensation + support from patient navigator Medium intensity HCV treatment adherence support: The medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks. | 9 | None | 10 | 320 | 0 | 320 | View |
| Arm 3: High Intensity Intervention (Elevated Risk) | Directly Observed Therapy with flexible dispensing and support from patient navigator High intensity HCV treatment adherence support: The high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed. | 7 | None | 11 | 475 | 1 | 475 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Event other than death | SYSTEMATIC_ASSESSMENT | General disorders | None | View |