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 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
NCT ID:
NCT03350620
Description:
Treatment-emergent adverse events (TEAEs) are defined as any new or worsening of existing adverse events that occur or worsen between the first dose date of a specific stage and the last dose date of the same stage.
All-cause mortality, serious AE and other AE reporting are based on the Safety Set. The Safety Set (SS) will include all subjects who were administered at least one dose of study medication in Stage 1 or Stage 2.
Frequency Threshold:
5
Time Frame:
3 years (Stage 1) and 1 year (Stage 2)
Study:
NCT03350620
Study Brief:
CHAMP: Study of NVK-002 in Children With Myopia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Stage 1: NVK-002 Concentration 1 | Stage 1: Subjects randomized to NVK-002 Concentration 1 NVK-002 Concentration 1: Study medication will be administered, once daily (QD) | 0 | None | 1 | 164 | 56 | 164 | View |
| Stage 1: NVK-002 Concentration 2 | Stage 1: Subjects randomized to NVK-002 Concentration 2 NVK-002 Concentration 2: Study medication will be administered, once daily (QD) | 0 | None | 8 | 247 | 92 | 247 | View |
| Stage 1: Vehicle (Placebo) | Stage 1: Subjects randomized to Vehicle (Placebo) Placebo: Vehicle (placebo) will be administered, once daily (QD). Note: N=162 for the safety set (see comment in participant flow) | 0 | None | 4 | 162 | 75 | 162 | View |
| Stage 2: NVK-002 Concentration 1 | Stage 2: Subjects randomized to NVK-002 Concentration 1 include those from Stage 1 NVK-002 concentration, Stage 1 NVK-002 concentration 2 and Stage 1 Vehicle (Placebo). | 0 | None | 3 | 159 | 43 | 159 | View |
| Stage 2: NVK-002 Concentration 2 | Stage 2: Subjects randomized to NVK-002 Concentration 2 include those from Stage 1 NVK-002 concentration 1, NVK-002 concentration 2, and Stage 1 Vehicle (Placebo). | 0 | None | 2 | 162 | 29 | 162 | View |
| Stage 2: Vehicle (Placebo) | Stage 2: Subjects randomized to Vehicle (Placebo) include those from Stage 1 NVK-002 concentration 1 and Stage 1 NVK-002 concentration 2. | 0 | None | 2 | 99 | 17 | 99 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| COVIV-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Parainfluenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Anal fisuure | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| suicide attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.0 | View |
| developmental hip dysplasia | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 25.0 | View |
| cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.0 | View |
| rectal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| Disruptive mood dysregulation disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| Mania | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| Ankle fracture | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| brain neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| hordeolum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| ocular hyperemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.0 | View |
| headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| seasonal allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.0 | View |
| pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |