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 @ 1:13 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
NCT ID:
NCT02204293
Description:
Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Frequency Threshold:
5
Time Frame:
Up to Month 27
Study:
NCT02204293
Study Brief:
Canakinumab for Treatment of Adult-onset Still'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 |
|---|---|---|---|---|---|---|---|---|
| Core Study Part I: Canakinumab | Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12. | 0 | None | 2 | 20 | 16 | 20 | View |
| Core Study Part I: Placebo | Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12. | 0 | None | 0 | 15 | 10 | 15 | View |
| Core Study Part II: Canakinumab Responders | Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20. | 0 | None | 1 | 14 | 13 | 14 | View |
| LTE Phase: Canakinumab | Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117). | 0 | None | 1 | 7 | 7 | 7 | View |
| Core Study Part II: Placebo Responders | Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20. | 0 | None | 1 | 2 | 2 | 2 | View |
| Core Study Part II: Placebo Non-responders | Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20. | 0 | None | 1 | 7 | 6 | 7 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Hepatotoxicity | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Chondromalacia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Patellofemoral pain syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Hypotonia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Medical device removal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (20.1) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.1) | View |
| Eyelid oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.1) | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Aphthous ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Injection site rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Primary biliary cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Hand-foot-and-mouth disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Infected bite | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Pertussis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Meniscus injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Appetite disorder | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Pseudarthrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Still's disease | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Tenosynovitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Anogenital warts | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Carpal tunnel syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Intercostal neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Vulva cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Nail dystrophy | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |