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 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
NCT ID:
NCT00370032
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00370032
Study Brief:
Study to Assess the Effect Of Alosetron On Mucosal Blood Flow
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| d-IBS Placebo | Diarrhea-predominant irritable bowel syndrome. Participants receiving 0.5 mb Placebo BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period. | None | None | 0 | 24 | 12 | 24 | View |
| d-IBS Alosetron | Diarrhea-predominant irritable bowel syndrome. Participants receiving 0.5 mb Alosetron BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period. | None | None | 0 | 23 | 10 | 23 | View |
| Healthy Volunteers Placebo | Volunteers without clinical disease. Participants receiving 0.5 mb Placebo BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period. | None | None | 0 | 24 | 11 | 24 | View |
| Healthy Volunteers Alosetron | Volunteers without clinical disease. Participants receiving 0.5 mb Alosetron BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period. | None | None | 0 | 23 | 11 | 23 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Distention | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Acarodermatitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Pharyngolaryngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Metrorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Micturition disorder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Micturition urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |