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 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
NCT ID:
NCT03451851
Description:
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
Frequency Threshold:
0
Time Frame:
PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Study:
NCT03451851
Study Brief:
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| PCP-Group 1 (Part 1): Placebo (Week 0-16) | Adolescent participants (aged \>=12 to \<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16. | 0 | None | 0 | 25 | 17 | 25 | View |
| PCP-Group 2 (Part 1): Guselkumab (Week 0-16) | Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16. | 0 | None | 1 | 41 | 17 | 41 | View |
| PCP-Group 3 (Part 1): Etanercept (Week 0-16) | Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \<63 kg and 50 mg for BW \>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \>=6 to \<12 years began receiving the same dose regimen starting from Week 0 until Week 16. | 0 | None | 0 | 26 | 15 | 26 | View |
| Withdrawal and Re-treatment Period-Group 1 (Part 1): Placebo to Guselkumab (Week 16-52) | Participants who received placebo during PCP were assessed for psoriasis area and severity index (PASI) response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 16, 20 and then every 8 weeks (q8w) thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \>= 50 percent (%) of their Week 16 PASI response, at which time they were treated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab q8w thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE. | 0 | None | 1 | 23 | 16 | 23 | View |
| Withdrawal and Re-treatment Period-Group 2 (Part 1): Guselkumab (Week 16-52) | Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \>= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE. | 0 | None | 0 | 41 | 29 | 41 | View |
| Withdrawal and Re-treatment Period- Group 3 (Part 1): Etanercept to Guselkumab (Week 16-52) | Participants who received etanercept during the PCP had the option to continue in the study or to discontinue the study. Participants that continued received weight-based doses of guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 20 and 24, followed by q8w dosing through Week 48 and remaining participants discontinued from the study. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE. | 0 | None | 0 | 22 | 13 | 22 | View |
| Part 2: Guselkumab (Week 0-52) | Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \[BW\] \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE. | 0 | None | 1 | 28 | 23 | 28 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chronic Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Radius Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.1 | View |
| Multiple Injuries | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 26.1 | View |
| Eosinophilia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 26.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 26.1 | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 26.1 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 26.1 | View |
| Ventricular Extrasystoles | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 26.1 | View |
| Blepharitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 26.1 | View |
| Conjunctivitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 26.1 | View |
| Myopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 26.1 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Aphthous Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Dental Caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Food Poisoning | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Mouth Ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Application Site Haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Influenza Like Illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Injection Site Erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Injection Site Haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Injection Site Induration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Injection Site Pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Injection Site Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Seasonal Allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 26.1 | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Acarodermatitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Bacterial Vulvovaginitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Chronic Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Ear Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Enterobiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Gastroenteritis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Gastrointestinal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Helminthic Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Hordeolum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Lice Infestation | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Molluscum Contagiosum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Otitis Externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Otitis Media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Tinea Capitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Tinea Versicolour | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Viral Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Viral Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Vulvovaginal Mycotic Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Arthropod Bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.1 | View |
| Foot Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.1 | View |
| Joint Dislocation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.1 | View |
| Ligament Rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.1 | View |
| Ligament Sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.1 | View |
| Limb Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.1 | View |
| Muscle Strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.1 | View |
| Peroneal Nerve Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.1 | View |
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| Aspartate Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| Blood Alkaline Phosphatase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| Blood Glucose Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| Blood Pressure Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| Blood Pressure Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| Cardiac Murmur | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| Liver Function Test Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| White Blood Cell Count Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| Malnutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Bone Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Ligament Laxity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Musculoskeletal Chest Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Musculoskeletal Discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.1 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.1 | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.1 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.1 | View |
| Pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA Version 26.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 26.1 | View |
| Attention Deficit Hyperactivity Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 26.1 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 26.1 | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Pleurisy | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Rhinitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Tonsillar Hypertrophy | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Dermatitis Contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Diffuse Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Lichen Planus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Night Sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 26.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Viral Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Suicidal Ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 26.1 | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 26.1 | View |
| Skin Hypopigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |