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 @ 4:20 PM
Ignite Modification Date:
2025-12-25 @ 2:16 PM
NCT ID:
NCT02357966
Description:
None
Frequency Threshold:
5
Time Frame:
The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Study:
NCT02357966
Study Brief:
Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized Subjects.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 514G3 (2 mg/kg) Plus Standard IV Antibiotic Therapy | The participants received single dose of 2 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy. | 0 | None | 1 | 3 | 2 | 3 | View |
| 514G3 (40 mg/kg) Plus Standard IV Antibiotic Therapy | The participants received single dose of 40 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy. | 0 | None | 1 | 6 | 5 | 6 | View |
| Placebo Plus Standard IV Antibiotic Therapy | A single dose of placebo plus standard IV antibiotic therapy. | 0 | None | 2 | 4 | 4 | 4 | View |
| 514G3 (10 mg/kg) Plus Standard IV Antibiotic Therapy | The participants received single dose of 10 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy. | 0 | None | 1 | 3 | 3 | 3 | View |
| Phase II: 40 mg/kg Study Drug (514G3) Plus Standard IV Antibiotic | The participants received single dose of 40 mg/kg study drug (5143G) plus standard IV therapy. | 0 | None | 6 | 24 | 19 | 24 | View |
| Phase II: Placebo Plus Standard Intravenous Therapy | The participants received single dose of placebo with standard IV therapy. | 0 | None | 5 | 12 | 9 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| AORTIC DISSECTION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| EMBOLIC STROKE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| DELIRIUM | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| PULMONARY OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| CARDIAC ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| HEPATIC CIRRHOSIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.1) | View |
| ABDOMINAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| ENDOCARDITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| LOCALISED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| OSTEOMYELITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| SEPTIC SHOCK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| SYSTEMIC CANDIDA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| ROAD TRAFFIC ACCIDENT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| EJECTION FRACTION DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| Acute respiratory insufficiency | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| Allergic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (19.1) | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| ATELECTASIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| BILATERAL AIRSPACE DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| BILATERAL LEG OEDEMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| SHOULDER PAIN BILATERAL | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| BLOOD BILIRUBIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BURNING SENSATION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| HYPOTENSION ACUTE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| PERINEAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| CARDIOMEGALY | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| COMMON COLD | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD CALCIUM DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| GRIP STRENGTH DECREASED | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| DELIRIUM | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| COUGH DRY | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| ALKALINE PHOSPHATASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD BILIRUBIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD NEUTROPHILS INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| WHITE BLOOD CELL COUNT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| EMPYEMA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| ENCEPHALOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| RASH PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| FLUSHING | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| BLOOD CHLORIDE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| FIBRINOGEN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD GLUCOSE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD POTASSIUM INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD PROTEIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| HYPERVOLAEMIA | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| HYPONATRAEMIA HYPERVOLAEMIC | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD ALBUMIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD CALCIUM DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD CHLORIDE DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD GLUCOSE DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD POTASSIUM DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD MAGNESIUM DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD SODIUM DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD PHOSPHATE DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD PROTEIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| HYPOTHYROIDISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (19.1) | View |
| PLATELET COUNT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| THROMBOSIS VENA CAVA INFERIOR | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| INFUSION SITE EXTRAVASATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| BLOOD UREA DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| EPISTAXIS SEVERE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| INTERSTITIAL OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| ALANINE AMINOTRANSFERASE DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| BLOOD BICARBONATE DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| LYMPHOCYTE COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| Non-sustained ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| Epidural abscess, paraspinal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Phlebitis injection site | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Scleral edema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| SCLERAL ICTERUS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| SKIN ULCERATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| PERICARDIAL EFFUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| NECK VENOUS THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| OSTEOMYELITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| KNEE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| MYOSITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| right arm and shoulder numbness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| Right Arm and Shoulder Tingling | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| SPLENOMEGALY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Acute blood loss | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| Acute on chronic congestive heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| Acute post-operative respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| ASPARTATE AMINOTRANSFERASE DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| PRESSURE ULCER STAGE II | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| SHORTNESS OF BREATH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| SYSTOLIC DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| POSTOPERATIVE RESPIRATORY DISTRESS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| SORE THROAT | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| RIGHT CHEST WALL MASS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| CHEST WALL PAIN | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |