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 @ 8:02 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
NCT ID:
NCT03099304
Description:
157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Frequency Threshold:
5
Time Frame:
Up to 180 weeks (156-week treatment period plus 6-month follow-up period)
Study:
NCT03099304
Study Brief:
A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Vehicle cream BID for 24 weeks (double-blind, vehicle-controlled treatment period), followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% once daily (QD), or 0.5% QD for Weeks 24 to 52 (continued double-blind treatment period), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period. | 0 | None | 0 | 32 | 14 | 32 | View |
| Ruxolitinib Cream 0.15% Once Daily (QD) | All participants who received at least one dose of ruxolitinib cream 0.15% QD (in the 52-week combined vehicle-controlled and continued double-blind periods). | 0 | None | 0 | 31 | 19 | 31 | View |
| Ruxolitinib Cream 0.5% QD | All participants who received at least one dose of ruxolitinib cream 0.5% QD. Treatment was received by participants for 52 weeks in the combined vehicle-controlled and continued double-blind periods, and by those participants who were randomized to the vehicle group or were randomized to ruxolitinib cream 0.15% QD and did not achieve 25% improvement in F-VASI score at Week 24 and crossed over to 0.5% QD for 28 weeks (Week 24 to Week 52 \[continued double-blind treatment period\]). | 0 | None | 2 | 45 | 23 | 45 | View |
| Ruxolitinib Cream 1.5% QD | All participants who received at least one dose of ruxolitinib cream 1.5% QD. Treatment was received by participants for 52 weeks in the combined vehicle-controlled and continued double-blind periods, and by those participants who were randomized to the vehicle group or were randomized to ruxolitinib cream 0.15% QD and did not achieve 25% improvement in F-VASI score at Week 24 and crossed over to 1.5% QD for 28 weeks (Week 24 to Week 52 \[continued double-blind treatment period\]). | 0 | None | 1 | 44 | 20 | 44 | View |
| Ruxolitinib Cream 1.5% BID | All participants who received at least one dose of ruxolitinib cream 1.5% BID. Treatment was received by (1) participants randomized to ruxolitinib cream 1.5% BID through Week 156, (2) participants who were randomized to the vehicle group or were randomized to ruxolitinib cream 0.15% QD and did not achieve 25% improvement in F-VASI score at Week 24 and crossed over to 1.5% BID for 28 weeks (Week 24 to Week 52 \[continued double-blind treatment period\]), and (3) participants who were (a) randomized to the vehicle group, (b) to ruxolitinib cream 0.15% QD and achieved 25% improvement in F-VASI score at Week 24, (c) to ruxolitinib cream 0.5% QD, and (d) to ruxolitinib cream 1.5% QD who crossed over to 1.5% BID during the open-label extension period. | 0 | None | 4 | 130 | 45 | 130 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Coronary artery occlusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Oesophageal achalasia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Application site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Application site exfoliation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Skin exfoliation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Application site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |