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 @ 10:19 PM
Ignite Modification Date:
2025-12-25 @ 7:52 PM
NCT ID:
NCT02871635
Description:
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
Frequency Threshold:
5
Time Frame:
From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Study:
NCT02871635
Study Brief:
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| BI 695501 (Baseline - Week 24 + 10 Weeks [70 Days]) | Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (CDAI decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection. | 0 | None | 6 | 72 | 23 | 72 | View |
| Humira (Baseline - Week 24 + 10 Weeks [70 Days]) | Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46). Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection. | 0 | None | 8 | 75 | 16 | 75 | View |
| BI 695501 (Week 24 - Week 46 + 10 Weeks [70 Days]) | Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (CDAI decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection. | 0 | None | 2 | 72 | 13 | 72 | View |
| Humira (Week 24 - Week 46 + 10 Weeks [70 Days]) | Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46). Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection. | 0 | None | 9 | 75 | 12 | 75 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Pulmonary tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Psoas abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Rotavirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Multiple sclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Crohn's disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Anal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Large intestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Pancreatitis chronic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Ruptured ectopic pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Palmoplantar pustulosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Pyoderma gangrenosum | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Crohn's disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |