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 @ 2:01 PM
Ignite Modification Date:
2025-12-25 @ 12:46 PM
NCT ID:
NCT03913195
Description:
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
Frequency Threshold:
5
Time Frame:
Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Study:
NCT03913195
Study Brief:
Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Sentinel Group-HIV + | Five (5) participants will receive two successive doses of 800mg ibalizumab administered in accordance with the prescribing information followed by five (5) successive 800mg doses on a schedule gradually increasing drug concentration and decreasing administration time. ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients. | 0 | None | 0 | 5 | 1 | 5 | View |
| Core Group- HIV+ | HIV-infected Core Group participants will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds. ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients. | 0 | None | 0 | 4 | 1 | 4 | View |
| Core Group-HIV Uninfected | Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds. ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients. | 0 | None | 0 | 13 | 8 | 13 | View |
| Intramuscular Injection Group-HIV+ | HIV+ participants in this group will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via intramuscular injection. ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients. | 0 | None | 0 | 7 | 4 | 7 | View |
| Intramuscular Injection Group-HIV Uninfected | Healthy Volunteer Intramuscular Injection Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via intramuscular injection. ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients. | 0 | None | 0 | 14 | 10 | 14 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| otitis media | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (10.0) | View |
| joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| abdominal distention | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| allergic rhinitis | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.0) | View |
| injection site pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| hyperglycemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (10.0) | View |
| hematoma at infusion site | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| bruising | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |