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 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
NCT ID:
NCT00577720
Description:
None
Frequency Threshold:
1
Time Frame:
14 Jul 2006 thru 27 Jan 2007
Study:
NCT00577720
Study Brief:
Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 35 mg IRBB (Immediate Release Before Breakfast) | 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks | None | None | 0 | 37 | 27 | 37 | View |
| 35 mg DRFB (Delayed Release Following Breakfast) | 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | None | None | 1 | 36 | 19 | 36 | View |
| 50 mg DRFB | 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | None | None | 0 | 36 | 24 | 36 | View |
| 50 mg DRBB (Delayed Release Before Breakfast) | 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks | None | None | 1 | 72 | 51 | 72 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| Pain in Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| Neck Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| Musculoskeletal Chest Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| Musculoskeletal Stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| Muscle Spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| Exostosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| Pain in Jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| Groin Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Abdominal Tenderness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Eructation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Abdominal Distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Gastrooesophageal Reflux Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Stomach Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Rectal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.0) | View |
| Sinus Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| Herpes Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| Herpes Simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| Gingival Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| Fungal Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| Viral Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| Nasal Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | View |
| Rhinitis Allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | View |
| Sinus Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | View |
| Pharyngolaryngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | View |
| Postnasal Drip | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.0) | View |
| Abnormal Dreams | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.0) | View |
| Ventricular Extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.0) | View |
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (9.0) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (9.0) | View |
| Conjunctival Haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (9.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Arthropod Bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.0) | View |
| Arthropod Sting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.0) | View |
| Soft Tissue Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.0) | View |
| Skin Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.0) | View |
| Blood Glucose Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.0) | View |
| Blood Cholesterol Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.0) | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.0) | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.0) | View |
| Blood Sodium Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.0) | View |
| Blood Triglycerides Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.0) | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (9.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.0) | View |