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 @ 2:04 PM
Ignite Modification Date:
2025-12-25 @ 12:48 PM
NCT ID:
NCT00678795
Description:
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
Frequency Threshold:
2.9
Time Frame:
All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
Study:
NCT00678795
Study Brief:
A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple Sclerosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Sativex | Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period. | None | None | 2 | 67 | 48 | 67 | View |
| Placebo | Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period. | None | None | 2 | 68 | 43 | 68 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 5.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 5.0 | View |
| Transient Ischaemic Attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 5.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 5.0 | View |
| Multiple Sclerosis Relapse | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 5.0 | View |
| Cystitis Haemorrhagic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 5.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting Not Otherwise Specified | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 5.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 5.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 5.0 | View |
| Diarrhoea Not Otherwise Specified | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 5.0 | View |
| Feeling Drunk | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 5.0 | View |
| Weakness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 5.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 5.0 | View |
| Application Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 5.0 | View |
| Urinary tract infection Not Otherwise Specified | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 5.0 | View |
| Cystitis Not Otherwise Specified | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 5.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 5.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 5.0 | View |
| Headache Not Otherwise Specified | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 5.0 | View |
| Balance Impaired Not Otherwise Specified | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 5.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 5.0 | View |
| Disorientation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 5.0 | View |
| Dissociation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 5.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 5.0 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 5.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 5.0 | View |
| Feeling Abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 5.0 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 5.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 5.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 5.0 | View |
| Pharyngitis Viral Not Otherwise Specified | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 5.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 5.0 | View |
| Neck Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | View |
| Disturbance in Attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 5.0 | View |
| Memory Impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 5.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 5.0 | View |
| Sweating Increased | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 5.0 | View |
| Multiple Sclerosis Relapse | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 5.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 5.0 | View |