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 @ 3:14 PM
Ignite Modification Date:
2025-12-25 @ 1:37 PM
NCT ID:
NCT01909492
Description:
None
Frequency Threshold:
0
Time Frame:
Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
Study:
NCT01909492
Study Brief:
Measurement of Relaxin Peptide in Multiple Sclerosis (MS)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group 1 | Group 1 will consist of 10 subjects with suspected MS, who have had a clinical attack within the last 12 weeks, have at least one gadolinium-enhancing lesion on brain or spinal cord MRI taken within the prior 4 weeks, and for which they have not received any immunomodulating or immunosuppressant medication. Patients will have a blood draw to provide serum and a CSF will be obtained through a lumbar puncture. Blood Draw: Patients will provide a serum sample for research. Lumbar Puncture: Patients will have a lumbar puncture to obtain CSF. | 0 | None | 0 | 10 | 5 | 10 | View |
| Group 2 | Group 2 will consist of 10 subjects with clinically stable definite MS, with no evidence of clinical relapse for at least the past 12 weeks, and have no gadolinium enhancing lesions on MRI in the prior 4 weeks. These subjects will fulfill the Revised (2010) McDonald's Criteria for the Diagnosis of MS. Patients will have a blood draw to provide serum and a CSF will be obtained through a lumbar puncture. Blood Draw: Patients will provide a serum sample for research. Lumbar Puncture: Patients will have a lumbar puncture to obtain CSF. | 0 | None | 0 | 10 | 9 | 10 | View |
| Group 3 | Group 3 will consist of 10 subjects without evidence of inflammatory systemic or inflammatory central nervous system disease, who require CSF removal for some other cause, such treatment of benign intracranial hypertension or as part of the procedure for insertion of an intrathecal medication delivery system. Patients will have a blood draw to provide serum and a CSF will be obtained through a lumbar puncture. Blood Draw: Patients will provide a serum sample for research. Lumbar Puncture: Patients will have a lumbar puncture to obtain CSF. | 0 | None | 0 | 10 | 10 | 10 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Generalized soreness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache/Headaches | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Low back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Back soreness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Low back tenderness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Back ache | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache secondary to lumbar puncture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Anxiety secondary to lumbar puncture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Headache post procedure | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Headache post LP | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Back pain secondary to lumbar puncture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Headache (localized to back of head) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Lightheaded | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Weakness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Minor back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Soreness at LP procedure site | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| mild upper respiratory congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |