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 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
NCT ID:
NCT00702468
Description:
All AEs occurring during the study were reported in the running logs at the back of the study case report form.
Frequency Threshold:
5
Time Frame:
All AEs occurring from the time of consent to post study follow up (Visit 3) i.e. 5 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of sudy medication were also collected.
Study:
NCT00702468
Study Brief:
Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to 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 | Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours. | None | None | 1 | 18 | 15 | 18 | View |
| Placebo | Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours. | None | None | 0 | 18 | 14 | 18 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | None | Gastrointestinal disorders | None | View |
| Mouth Ulceration | None | Gastrointestinal disorders | None | View |
| Stomach Discomfort | None | Gastrointestinal disorders | None | View |
| Vomitting | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Pain | None | General disorders | None | View |
| Application site pain | None | General disorders | None | View |
| Asthenia | None | General disorders | None | View |
| Gait disturbance | None | General disorders | None | View |
| Urinary tract infection | None | Infections and infestations | None | View |
| Cystitis | None | Infections and infestations | None | View |
| Lower respiratory tract infection | None | Infections and infestations | None | View |
| Nasopharyngitis | None | Infections and infestations | None | View |
| Oral Herpes | None | Infections and infestations | None | View |
| Contusion | None | Injury, poisoning and procedural complications | None | View |
| Gamma-glutamyltransferase increase | None | Investigations | None | View |
| Anorexia | None | Metabolism and nutrition disorders | None | View |
| Muscle spasms | None | Musculoskeletal and connective tissue disorders | None | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal stiffness | None | Musculoskeletal and connective tissue disorders | None | View |
| Joint stiffness | None | Musculoskeletal and connective tissue disorders | None | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal Discomfort | None | Musculoskeletal and connective tissue disorders | None | View |
| Neck pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Sensation of heaviness | None | Musculoskeletal and connective tissue disorders | None | View |
| Muscle spasticity | None | Nervous system disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Somnolence | None | Nervous system disorders | None | View |
| Tremor | None | Nervous system disorders | None | View |
| Multiple Sclerosis | None | Nervous system disorders | None | View |
| Hyperaesthesia | None | Nervous system disorders | None | View |
| Paraesthesia | None | Nervous system disorders | None | View |
| Trigeminal neuralgia | None | Nervous system disorders | None | View |
| Depressed mood | None | Psychiatric disorders | None | View |
| Insomnia | None | Psychiatric disorders | None | View |
| Sleep disorder | None | Psychiatric disorders | None | View |
| Haematuria | None | Renal and urinary disorders | None | View |
| Hypertonic Bladder | None | Renal and urinary disorders | None | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pharyngolaryngeal pain | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Rash | None | Skin and subcutaneous tissue disorders | None | View |
| Skin tightness | None | Skin and subcutaneous tissue disorders | None | View |
| Hot flush | None | Vascular disorders | None | View |
| Hypertension | None | Vascular disorders | None | View |