Adverse Events Module

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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 @ 2:22 AM
Ignite Modification Date: 2025-12-26 @ 12:54 AM
NCT ID: NCT03941834
Description: Treated analysis set evaluated.
Frequency Threshold: 0
Time Frame: Day 1 up to 2 weeks of follow up post-last dose in the study (Maximum up to 19 weeks)
Study: NCT03941834
Study Brief: Trial for Treatment Refractory Trigeminal Neuralgia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DBT Phase/ Treatment Sequence 2/ Period 2: Placebo Participants included in this arm were randomized to second sequence to receive placebo (matched to rimegepant) orally QD for 2 weeks in Period 2. 0 None 0 14 0 14 View
DBT Phase: Pooled Rimegepant Participants who received rimegepant 75 mg IR tablet in treatment period 1 or 2 of DBT phase. 0 None 0 28 6 28 View
DBT Phase: Pooled Placebo Participants who received placebo matched to rimegepant in treatment period 1 or 2 of DBT phase. 0 None 0 29 1 29 View
OLE Phase: Rimegepant Participants received rimegepant 75 mg ODT QD for 12 weeks in OLE phase. 0 None 0 13 4 13 View
DBT Phase/ Treatment Sequence 1/ Period 2: Rimegepant Participants included in this arm were randomized to first sequence to receive rimegepant 75 mg IR tablet orally QD for 2 weeks in Period 2. 0 None 0 14 3 14 View
DBT Phase/ Treatment Sequence 2/ Period 1: Rimegepant Participants included in this arm were randomized to second sequence to receive rimegepant 75 mg IR tablet orally QD for 2 weeks in Period 1. 0 None 0 14 3 14 View
DBT Phase/ Treatment Sequence 1/ Period 1: Placebo Participants included in this arm were randomized to first sequence to receive placebo (matched to rimegepant) orally QD for 2 weeks in Period 1. 0 None 0 15 1 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Trigeminal neuralgia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Abdominal tenderness NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View