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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
NCT ID:
NCT02151994
Description:
None
Frequency Threshold:
0
Time Frame:
Just before drug administration and twice daily until 72 h after (last) drug administration
Study:
NCT02151994
Study Brief:
Safety, Tolerability, Pharmacokinetic, Including Food Interaction, and Pharmacodynamic Profile of BIA 5-1058.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo (SAD) | SAD period | None | None | 0 | 18 | 11 | 18 | View |
| 5 mg (SAD) | SAD period | None | None | 0 | 6 | 0 | 6 | View |
| 25 mg (SAD) | SAD period | None | None | 0 | 6 | 2 | 6 | View |
| 50 mg (SAD) | SAD period | None | None | 0 | 6 | 3 | 6 | View |
| 100 mg (SAD) | SAD period | None | None | 0 | 6 | 2 | 6 | View |
| 200 mg (SAD) | SAD period | None | None | 0 | 6 | 4 | 6 | View |
| 400 mg (SAD) | SAD period | None | None | 0 | 6 | 4 | 6 | View |
| 800 mg (SAD) | SAD period | None | None | 0 | 6 | 3 | 6 | View |
| 1600 mg (SAD) | SAD period | None | None | 0 | 6 | 1 | 6 | View |
| 2400 mg (SAD) | SAD period | None | None | 0 | 6 | 4 | 6 | View |
| 400 mg Fasted (FE Period) | FE period | None | None | 0 | 12 | 3 | 12 | View |
| 400 mg Fed (FE Period) | FE period | None | None | 0 | 12 | 5 | 12 | View |
| Placebo (MAD Period) | MAD period | None | None | 0 | 10 | 8 | 10 | View |
| 50 mg (MAD Period) | MAD period | None | None | 0 | 6 | 5 | 6 | View |
| 100 mg (MAD Period) | MAD period | None | None | 0 | 6 | 3 | 6 | View |
| 200 mg (MAD Period) | MAD period | None | None | 0 | 6 | 5 | 6 | View |
| 400 mg (MAD Period) | MAD period | None | None | 0 | 6 | 3 | 6 | View |
| 1200 mg (MAD Period) | MAD period | None | None | 0 | 6 | 6 | 6 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| gastrointestinal sounds abnormal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| application site irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| application site rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| catheter site related reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| feeling of relaxation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| muscle injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| dizziness postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| lip dry | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| vessel puncture site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| papule | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| faeces discoloured | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| axillary pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| catheter site related inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| feeling drunk | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| hunger | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| catheter site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| arthropod sting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| hypnagogic hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| panic attack | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| dry throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| seborrhoeic dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |