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 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
NCT ID:
NCT03963232
Description:
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Per protocol, AE analysis was planned per treatment regimen received in each study phase
Frequency Threshold:
5
Time Frame:
Baseline to Follow-up (Up To 10 months)
Study:
NCT03963232
Study Brief:
A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo/Galcanezumab 120mg - Open-Label Treatment Phase | After completion of Placebo double-blind phase, participants had an option to enter open-label treatment phase where they received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months. | 0 | None | 9 | 241 | 12 | 241 | View |
| Placebo - Follow-up | Participants entered follow-up phase from Placebo double-blind treatment phase and were observed for 4 months. No treatments administered. | 0 | None | 0 | 7 | 0 | 7 | View |
| Placebo - Double-Blind Treatment Phase | Participants received placebo once per month SC for 3 months during this phase. | 0 | None | 3 | 259 | 29 | 259 | View |
| Galcanezumab 120mg - Double-Blind Treatment Phase | Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months. | 0 | None | 2 | 261 | 32 | 261 | View |
| Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment Phase | After completion of Galcanezumab 120mg double-blind phase, participants had an option to enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months. | 0 | None | 3 | 243 | 7 | 243 | View |
| Galcanezumab 120mg - Follow-up | Participants entered follow-up phase from Galcanezumab 120mg double-blind treatment phase and were observed for 4 months. No treatments administered. | 0 | None | 0 | 11 | 0 | 11 | View |
| Placebo/Galcanezumab 120mg - Follow-up | Participants entered follow-up phase from Placebo/Galcanezumab 120 mg open-label treatment phase and were observed for 4 months. No treatments administered. | 0 | None | 3 | 236 | 0 | 236 | View |
| Galcanezumab 120mg/Galcanezumab 120mg - Follow-up | Participants entered follow-up phase from Galcanezumab 120mg/Galcanezumab 120mg open-label treatment phase and were observed for 4 months. No treatments administered. | 0 | None | 4 | 236 | 0 | 236 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thymic cyst | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 24.1 | View |
| Uterine polyp | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 24.1 | View |
| Nasal septum deviation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 24.1 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Covid-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Infected dermal cyst | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Mastitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Mucosal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.1 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.1 | View |
| Traumatic ulcer | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | View |
| Carpal tunnel syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Tension headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Thoracic outlet syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Abortion threatened | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | View |
| Ectopic pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | View |
| Borderline personality disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.1 | View |