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 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
NCT ID:
NCT04667104
Description:
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Frequency Threshold:
5
Time Frame:
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Study:
NCT04667104
Study Brief:
A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | Participants received a single dose of JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as a subcutaneous injection (SC) every 4 weeks (Q4W) along with JNJ-56136379 (JNJ-6379) 250 mg tablet once daily (QD) and nucleos(t)ide analog (NA) treatment (either entecavir\[ETV\] 0.5 mg, tenofovir disoproxil fumarate\[TDF\] 245 mg, or tenofovir alafenamide\[TAF\] 25 mg) QD up to 12 weeks in TP 1. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after protocol amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only. Participants were assessed for eligibility criteria for PegIFN-alpha 2a at Week 12. Participants who met the criteria entered TP 2. | 0 | None | 0 | 48 | 12 | 48 | View |
| TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only. | 0 | None | 1 | 48 | 35 | 48 | View |
| Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4). | 0 | None | 4 | 48 | 20 | 48 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| Hepatic Mass | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Gastric Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Hydronephrosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Ureterolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Prostatitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Injection Site Erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Neutrophil Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Influenza Like Illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |