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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
NCT ID:
NCT03519867
Description:
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
Frequency Threshold:
5
Time Frame:
Up to 7 days
Study:
NCT03519867
Study Brief:
Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg | Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. | 0 | None | 0 | 6 | 6 | 6 | View |
| 3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg | Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. | 0 | None | 0 | 5 | 3 | 5 | View |
| 4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg | Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. | 0 | None | 1 | 3 | 1 | 3 | View |
| 5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg | Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. | 0 | None | 1 | 5 | 4 | 5 | View |
| 7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg | Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. | 0 | None | 0 | 4 | 4 | 4 | View |
| 8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg | Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. | 0 | None | 1 | 4 | 4 | 4 | View |
| 9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg | Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. | 0 | None | 0 | 3 | 2 | 3 | View |
| 1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg | Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. | 0 | None | 1 | 5 | 5 | 5 | View |
| 6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg | Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. | 0 | None | 0 | 4 | 4 | 4 | View |
| 10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg | Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. | 0 | None | 0 | 4 | 2 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Postoperative fever | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 08.0 | View |
| Procedural complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 08.0 | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 08.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 08.0 | View |
| Respiratory depression | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 08.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 08.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Post procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 08.0 | View |
| Post procedural vomiting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 08.0 | View |
| Beta 2 microglobulin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 08.0 | View |
| Beta-N-acetyl-D-glucosaminidase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 08.0 | View |
| Blood albumin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 08.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 08.0 | View |
| Genital burning sensation | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 08.0 | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 08.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 08.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 08.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 08.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 08.0 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 08.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 08.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 08.0 | View |
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 08.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 08.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 08.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 08.0 | View |
| Catheter site related reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 08.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 08.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 08.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 08.0 | View |
| Airway complication of anaesthesia | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 08.0 | View |
| Operative haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 08.0 | View |
| Post procedural nausea | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 08.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 08.0 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 08.0 | View |
| Electrocardiogram QT prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 08.0 | View |
| Haematocrit decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 08.0 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 08.0 | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 08.0 | View |
| Protein total decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 08.0 | View |
| White blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 08.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 08.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 08.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 08.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 08.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 08.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 08.0 | View |
| Neuromuscular blockade | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 08.0 | View |
| Stupor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 08.0 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 08.0 | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 08.0 | View |
| Bladder discomfort | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 08.0 | View |