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 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
NCT ID:
NCT01154218
Description:
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01154218
Study Brief:
Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Crizotinib IRT Fasted | Single oral dose of crizotinib 250 mg IRT (Treatment A \[Reference 1\]) in fasted state in any intervention period. | None | None | 0 | 36 | 21 | 36 | View |
| Crizotinib PIC Fasted | Single oral dose of crizotinib 250 mg PIC (Treatment B \[Reference 2\]) in fasted state in any intervention period. | None | None | 0 | 36 | 24 | 36 | View |
| Crizotinib CIC Fasted | Single oral dose of crizotinib 250 mg CIC (Treatment C \[Test for bioequivalence (BE), Reference for Food effect\]) in fasted state in any intervention period. | None | None | 0 | 36 | 20 | 36 | View |
| Crizotinib CIC Fed | Single oral dose of crizotinib 250 mg CIC (Treatment D \[Test High Fat\]) in fed state in any intervention period. | None | None | 0 | 36 | 21 | 36 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Epigastric discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Gastrointestinal sounds abnormal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Gingivitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Salivary hypersecretion | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Feeling cold | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Joint sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.1 | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Dizziness postural | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.1 | View |