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 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
NCT ID:
NCT04804033
Description:
None
Frequency Threshold:
0
Time Frame:
DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase
Study:
NCT04804033
Study Brief:
A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Zavegepant 200 mg (DBT) | Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 12 weeks in DBT phase. | 0 | None | 1 | 175 | 8 | 175 | View |
| Placebo (DBT) Matched to Zavegepant 100 mg | Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase. | 0 | None | 0 | 86 | 13 | 86 | View |
| Placebo (DBT) Matched to Zavegepant 200 mg | Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase. | 0 | None | 1 | 88 | 11 | 88 | View |
| Zavegepant 100 mg (OLE) | Participants who received Zavegepant 100 mg orally as soft gelatin capsules (25 mg \*4 capsules) daily for 52 weeks in OLE phase. | 0 | None | 1 | 155 | 12 | 155 | View |
| Zavegepant 200 mg (OLE) | Participants who received Zavegepant 200 mg orally as soft gelatin capsules (25 mg \*8 capsules) daily for 52 weeks in OLE phase. | 0 | None | 3 | 143 | 12 | 143 | View |
| Zavegepant 100 mg DBT/Zavegepant 100 mg OLE: Follow-up | Participants who received Zavegepant 100 mg in DBT phase or in DBT and OLE phases and were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase. | 0 | None | 0 | 154 | 0 | 154 | View |
| Placebo Matched to Zavegepant 100 mg (DBT)/ Zavegepant 100 mg OLE: Follow-up | Participants who received Placebo matched to Zavegepant 100 mg in DBT phase or Placebo matched to Zavegepant 100 mg in DBT phase and Zavegepant 100 mg in OLE phase, were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase. | 0 | None | 1 | 47 | 0 | 47 | View |
| Placebo Matched to Zavegepant 200 mg (DBT)/ Zavegepant 200 mg OLE: Follow-up | Participants who received Placebo matched to Zavegepant 200 mg in DBT phase or Placebo matched to Zavegepant 200 mg in DBT phase and Zavegepant 200 mg in OLE phase, were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase. | 0 | None | 0 | 48 | 0 | 48 | View |
| Placebo Pooled (DBT)/No Zavegepant OLE: Follow-up | Participants who received Placebo matched to Zavegepant 100 mg or 200 mg in DBT phase and no Zavegepant in OLE phase were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT phase. | 0 | None | 0 | 70 | 0 | 70 | View |
| Zavegepant 100 mg (DBT) | Participants were randomized to receive Zavegepant 100 mg orally as soft gelatin capsules (25 mg \*4 capsules) daily for 12 weeks in DBT phase. | 1 | None | 1 | 173 | 14 | 173 | View |
| Zavegepant Pooled (DBT) | Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. | 0 | None | 2 | 348 | 22 | 348 | View |
| Placebo Pooled (DBT) | Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase. | 0 | None | 1 | 174 | 24 | 174 | View |
| Zavegepant 200 mg DBT/ Zavegepant 200 mg OLE: Follow-up | Participants who received Zavegepant 200 mg in DBT phase or in DBT and OLE phases and were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase. | 0 | None | 1 | 162 | 0 | 162 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Iron deficiency anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 27.0 | View |
| Hypertensive heart disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA27.0 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA27.0 | View |
| Intervertebral disc disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA27.0 | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA27.0 | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA27.0 | View |
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA27.0 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA27.0 | View |
| Lung disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA27.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA27.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA27.0 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA27.0 | View |