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:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
NCT ID:
NCT02877134
Description:
The Safety Analysis Set included all randomized participants who received at least 1 dose of study agent (placebo or JNJ-64304500 or ustekinumab, including a partial dose).
Frequency Threshold:
5
Time Frame:
Part I: Through Week 38; Part II: Through Week 24 for participants who entered the LTE and through Week 36 for participants who did not enter the LTE; Part II LTE: from Week 24 through Week 88
Study:
NCT02877134
Study Brief:
Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part II: JNJ-64304500 Low Dose | Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36. | 0 | None | 3 | 50 | 24 | 50 | View |
| Part II: JNJ-64304500 Middle Dose | Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36. | 0 | None | 0 | 49 | 23 | 49 | View |
| Part II LTE: Placebo to JNJ-64304500 Middle Dose | Participants randomized to placebo group and had dose adjustment to JNJ-64304500 middle dose at Week 12 and continued to receive JNJ-64304500 middle dose (JNJ-64304500 75 mg) SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72 in the Part II LTE. Participants were followed up for safety up to Week 88. | 0 | None | 3 | 12 | 5 | 12 | View |
| Part II LTE: JNJ-64304500 Low Dose | Participants randomized to the 'JNJ-64304500 Low Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 25 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88. | 0 | None | 2 | 21 | 6 | 21 | View |
| Part I: Placebo to JNJ-64304500 | Participants received placebo SC at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo Q2W through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 mg SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Safety results included data from the time of receiving JNJ- 64304500 at Week 12 onward. Participants were followed up for safety up to Week 38. | 0 | None | 2 | 44 | 10 | 44 | View |
| Part I: JNJ-64304500 | Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. Participants were followed up for safety up to Week 38. | 1 | None | 8 | 73 | 38 | 73 | View |
| Part II: Placebo | Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ 64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Safety results included data up to the time of receiving JNJ- 64304500 for those who received JNJ-64304500 at Week 12 and included all data for those who did not receive JNJ-64304500 at Week 12. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36. | 0 | None | 3 | 48 | 16 | 48 | View |
| Part II: Placebo to JNJ-64304500 Middle Dose | Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ 64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Safety results included data from the time of receiving JNJ- 64304500 at Week 12 onward. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36. | 0 | None | 0 | 31 | 6 | 31 | View |
| Part II: JNJ-64304500 High Dose | Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36. | 1 | None | 6 | 49 | 26 | 49 | View |
| Part II: Ustekinumab | Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously \[IV\]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight \[less than or equal to \[\<=\] 55 kg). - Ustekinumab 390 mg (weight greater than \[\>\] 55 kg and less than or equal to \[\<=\] 85 kg). Ustekinumab 520 mg (weight \>85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36. | 0 | None | 2 | 47 | 20 | 47 | View |
| Part II LTE: Placebo | Participants randomized to placebo group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received placebo at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88. | 0 | None | 1 | 10 | 5 | 10 | View |
| Part II LTE: JNJ-64304500 Middle Dose | Participants randomized to the 'JNJ-64304500 Middle Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 75 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88. | 0 | None | 5 | 27 | 12 | 27 | View |
| Part II LTE: JNJ-64304500 High Dose | Participants randomized to the 'JNJ-64304500 High Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 200 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88. | 0 | None | 5 | 24 | 10 | 24 | View |
| Part II LTE: Ustekinumab | Participants randomized to the 'Ustekinumab' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received Ustekinumab 90 mg IV at Weeks 24, 32, 40, 48, 56, 64 and 72. Participants were followed up for safety up to Week 88. | 0 | None | 5 | 28 | 9 | 28 | View |
| Part I: Placebo | Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 mg SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Safety results included data up to the time of receiving JNJ-64304500 for those who received JNJ-64304500 at Week 12 and included all data for those who did not receive JNJ-64304500 at Week 12. Participants were followed up for safety up to Week 38. | 0 | None | 1 | 72 | 24 | 72 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.1 | View |
| Cardiac Arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.1 | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.1 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Ileal Perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Ileal Stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Large Intestine Perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Small Intestinal Obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.1 | View |
| Acute Hepatic Failure | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 23.1 | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 23.1 | View |
| Anal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.1 | View |
| Device Related Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.1 | View |
| Gastroenteritis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.1 | View |
| Peritonitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.1 | View |
| Salmonellosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.1 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Urinary Tract Infection Bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.1 | View |
| Hand Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.1 | View |
| Radius Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.1 | View |
| Lipase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.1 | View |
| Malnutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.1 | View |
| Foot Deformity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | View |
| Benign Ovarian Tumour | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | View |
| Squamous Cell Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | View |
| Uterine Leiomyoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.1 | View |
| Depression Suicidal | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 23.1 | View |
| Ovarian Cyst Ruptured | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 23.1 | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | View |
| Deep Vein Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.1 | View |
| Small Intestinal Stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Crohn's Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.1 | View |
| Iron Deficiency Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.1 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.1 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 23.1 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Crohn's Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Enterovesical Fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Gastric Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Gastrooesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.1 | View |
| Blood Alkaline Phosphatase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.1 | View |
| Lymphocyte Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.1 | View |
| Neutrophil Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.1 | View |
| Platelet Count Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.1 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.1 | View |
| White Blood Cell Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.1 | View |
| Hypophosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | View |
| Tumour Inflammation | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | View |