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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
NCT ID:
NCT01801358
Description:
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
Frequency Threshold:
5
Time Frame:
Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
Study:
NCT01801358
Study Brief:
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS) | Phase Ib (Dose Escalation) Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid. | None | None | 3 | 6 | 6 | 6 | View |
| Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS) | Phase Ib (Dose Escalation) Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid. | None | None | 1 | 6 | 6 | 6 | View |
| Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS) | Phase Ib (Dose Escalation) Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid. | None | None | 2 | 6 | 6 | 6 | View |
| Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS) | Phase Ib (Dose Escalation) Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid. | None | None | 6 | 8 | 8 | 8 | View |
| Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS) | Phase Ib (Dose Escalation) Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid. | None | None | 3 | 6 | 6 | 6 | View |
| Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS) | Phase Ib (Dose Escalation) Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid. | None | None | 4 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| BLOOD CREATININE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| SINUS TACHYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| PNEUMOTHORAX | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| PULMONARY EMBOLISM | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| MALAISE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| OEDEMA PERIPHERAL | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| ASCITES | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| GASTROINTESTINAL HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| OESOPHAGEAL VARICES HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| ACUTE HEPATIC FAILURE | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.0) | View |
| HEPATIC FAILURE | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.0) | View |
| HEPATOMEGALY | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.0) | View |
| HYPOTHYROIDISM | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (18.0) | View |
| DEHYDRATION | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| HYPOCALCAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| ESCHERICHIA BACTERAEMIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| ACUTE KIDNEY INJURY | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| HYPOALBUMINAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| HYPOKALAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| CACHEXIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| RASH PUSTULAR | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| HYPERTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| TUMOUR PAIN | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| OEDEMA PERIPHERAL | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| ASTHENIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| MALAISE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| CHILLS | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| ANXIETY | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.0) | View |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| WEIGHT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| ALANINE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| EJECTION FRACTION DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| LYMPHOCYTE COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| BLOOD CREATININE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| BLOOD LACTATE DEHYDROGENASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| WEIGHT INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| THROMBOCYTOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| DYSGEUSIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| CEREBROVASCULAR DISORDER | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| NEUROPATHY PERIPHERAL | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| PRESYNCOPE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| CHORIORETINOPATHY | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.0) | View |
| RETINAL DETACHMENT | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.0) | View |
| VISION BLURRED | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.0) | View |
| VISUAL IMPAIRMENT | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.0) | View |
| CATARACT | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.0) | View |
| EYE DISORDER | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.0) | View |
| EYELID OEDEMA | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.0) | View |
| MACULAR OEDEMA | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.0) | View |
| PERIORBITAL OEDEMA | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.0) | View |
| RETINAL OEDEMA | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.0) | View |
| RETINOPATHY | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.0) | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| STOMATITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| DYSPEPSIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| FLATULENCE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| DRY MOUTH | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| ABDOMINAL PAIN UPPER | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| GASTRITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| IMPAIRED GASTRIC EMPTYING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| HEPATIC PAIN | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.0) | View |
| CHROMATURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.0) | View |
| RENAL COLIC | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.0) | View |
| RASH | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| DERMATITIS ACNEIFORM | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| PRURITUS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| DRY SKIN | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| ACNE | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| RASH MACULO-PAPULAR | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| ALOPECIA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| PAIN OF SKIN | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| ERYTHEMA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| HYPERHIDROSIS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| RASH FOLLICULAR | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| XERODERMA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| MYALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| BACK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| MUSCLE SPASMS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| DECREASED APPETITE | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| DEHYDRATION | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| HYPERKALAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |