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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
NCT ID:
NCT04000594
Description:
None
Frequency Threshold:
5
Time Frame:
The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.
Study:
NCT04000594
Study Brief:
A Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 (RG6042) in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 30 MG RG6042 | Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29. | 0 | None | 0 | 4 | 4 | 4 | View |
| 60 MG RG6042 | Participants will receive dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29 | 0 | None | 1 | 4 | 4 | 4 | View |
| 120 MG RG6042 | Participants will receive dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29. | 0 | None | 1 | 4 | 4 | 4 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MeDRA v 25.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA v 25.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA v 25.0 | View |
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA v 25.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA v 25.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA v 25.0 | View |
| Catheter site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MeDRA v 25.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MeDRA v 25.0 | View |
| Medical device site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MeDRA v 25.0 | View |
| Medical device site vesicles | NON_SYSTEMATIC_ASSESSMENT | General disorders | MeDRA v 25.0 | View |
| Puncture site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MeDRA v 25.0 | View |
| Vessel puncture site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MeDRA v 25.0 | View |
| Xerosis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MeDRA v 25.0 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA v 25.0 | View |
| Pelvic inflammatory disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA v 25.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA v 25.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA v 25.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA v 25.0 | View |
| Post lumbar puncture syndrome | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA v 25.0 | View |
| Procedural headache | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA v 25.0 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA v 25.0 | View |
| Skin laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA v 25.0 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MeDRA v 25.0 | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA v 25.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA v 25.0 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA v 25.0 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA v 25.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA v 25.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA v 25.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA v 25.0 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA v 25.0 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA v 25.0 | View |
| Radicular pain | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA v 25.0 | View |
| Tension headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA v 25.0 | View |
| Confusional state | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA v 25.0 | View |
| Panic attack | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA v 25.0 | View |
| Uterine adhesions | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MeDRA v 25.0 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA v 25.0 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA v 25.0 | View |