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 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
NCT ID:
NCT01950520
Description:
None
Frequency Threshold:
0
Time Frame:
Twelve weeks
Study:
NCT01950520
Study Brief:
Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 1 Low Temperature : Placebo | Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only) Within each block, the following five interventions will be repeated: Propranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only) Pindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only) Dantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only) Magnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only) Placebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only) | 0 | None | 0 | 16 | 0 | 16 | View |
| Cohort 1 Low Temperature : Proprannolol | Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only) Within each block, the following five interventions will be repeated: Propranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only) Pindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only) Dantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only) Magnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only) Placebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only) | 0 | None | 0 | 16 | 0 | 16 | View |
| Cohort 1 Low Temperature : Dantrolene | Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only) Within each block, the following five interventions will be repeated: Propranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only) Pindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only) Dantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only) Magnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only) Placebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only) | 0 | None | 0 | 16 | 0 | 16 | View |
| Cohort 1 Low Temperature : Magnesium | Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only) Within each block, the following five interventions will be repeated: Propranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only) Pindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only) Dantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only) Magnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only) Placebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only) | 0 | None | 0 | 16 | 1 | 16 | View |
| Cohort 1 Low Temperature : Pindolol | Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only) Within each block, the following five interventions will be repeated: Propranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only) Pindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only) Dantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only) Magnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only) Placebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only) | 0 | None | 0 | 16 | 0 | 16 | View |
| Cohort 1 High Temperature : Placebo | Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only) Within each block, the following five interventions will be repeated: Propranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only) Pindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only) Dantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only) Magnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only) Placebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only) | 0 | None | 0 | 16 | 0 | 16 | View |
| Cohort 1 High Temperature : Proprannolol | Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only) Within each block, the following five interventions will be repeated: Propranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only) Pindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only) Dantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only) Magnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only) Placebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only) | 0 | None | 0 | 16 | 1 | 16 | View |
| Cohort 1 High Temperature : Dantrolene | Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only) Within each block, the following five interventions will be repeated: Propranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only) Pindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only) Dantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only) Magnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only) Placebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only) | 0 | None | 0 | 16 | 0 | 16 | View |
| Cohort 1 High Temperature : Magnesium | Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only) Within each block, the following five interventions will be repeated: Propranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only) Pindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only) Dantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only) Magnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only) Placebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only) | 0 | None | 0 | 16 | 0 | 16 | View |
| Cohort 1 High Temperature : Pindolol | Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only) Within each block, the following five interventions will be repeated: Propranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only) Pindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only) Dantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only) Magnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only) Placebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only) | 0 | None | 0 | 16 | 1 | 16 | View |
| Cohort 2 : Placebo | Interventions, in random order, will be administered during one of the six one-day stays Caffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only) Qsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only) Topiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only) Phentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only) Naltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only) Placebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only) | 0 | None | 0 | 18 | 0 | 18 | View |
| Cohort 2 : Caffeine | Interventions, in random order, will be administered during one of the six one-day stays Caffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only) Qsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only) Topiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only) Phentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only) Naltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only) Placebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only) | 0 | None | 0 | 18 | 0 | 18 | View |
| Cohort 2 : Naltrexone | Interventions, in random order, will be administered during one of the six one-day stays Caffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only) Qsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only) Topiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only) Phentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only) Naltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only) Placebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only) | 0 | None | 0 | 18 | 5 | 18 | View |
| Cohort 2 : Qsymia | Interventions, in random order, will be administered during one of the six one-day stays Caffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only) Qsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only) Topiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only) Phentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only) Naltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only) Placebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only) | 0 | None | 0 | 18 | 2 | 18 | View |
| Cohort 2 : Topiramate | Interventions, in random order, will be administered during one of the six one-day stays Caffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only) Qsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only) Topiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only) Phentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only) Naltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only) Placebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only) | 0 | None | 0 | 18 | 5 | 18 | View |
| Cohort 2 : Phentermine | Interventions, in random order, will be administered during one of the six one-day stays Caffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only) Qsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only) Topiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only) Phentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only) Naltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only) Placebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only) | 0 | None | 0 | 18 | 2 | 18 | View |
| Cohort 3 : Placebo | Interventions, in random order, will be administered during one of the four overnight inpatient stays Mirabegron 50mg: Mirabegron 50mg, oral, by mouth (Cohort 3 only) Mirabegron 200mg: Mirabegron 200mg, oral, by mouth (Cohort 3 only) Placebo for Mirabegron: Placebo for Mirabegron, oral, by mouth (Cohort 3 only) | 0 | None | 0 | 13 | 1 | 13 | View |
| Cohort 3 : Mirabegron 50mg | Interventions, in random order, will be administered during one of the four overnight inpatient stays Mirabegron 50mg: Mirabegron 50mg, oral, by mouth (Cohort 3 only) Mirabegron 200mg: Mirabegron 200mg, oral, by mouth (Cohort 3 only) Placebo for Mirabegron: Placebo for Mirabegron, oral, by mouth (Cohort 3 only) | 0 | None | 0 | 13 | 1 | 13 | View |
| Cohort 3 : Mirabegron 200mg | Interventions, in random order, will be administered during one of the four overnight inpatient stays Mirabegron 50mg: Mirabegron 50mg, oral, by mouth (Cohort 3 only) Mirabegron 200mg: Mirabegron 200mg, oral, by mouth (Cohort 3 only) Placebo for Mirabegron: Placebo for Mirabegron, oral, by mouth (Cohort 3 only) | 0 | None | 0 | 13 | 1 | 13 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Asymptomatic non-sustained ventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Catheter-related asymptomatic uncomplicated right upper extremity superficial venous thrombophlebiti | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Presyncopal episode, likely vasovagal response | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Right lower lung subcentimeter pleural based nodular density | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Incidental PET CT- Right upper lung subcentimeter nodule associated with hypermetabolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Incidental PET CT- Nonspecific subpleural nodules | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Presyncopal episode, likely vasovagal response | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Feels foggy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Drowsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Feels edgy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |