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 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
NCT ID:
NCT01744704
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01744704
Study Brief:
Study to Evaluate Safety, Tolerability and Pharmacokinetics of rhNGF Eye Drops in Healthy Volunteers
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| rhNGF 5 µg/mL Sentinel | 1 x 35 µL drop 3 subjects rhNGF 5 µg/mL Sentinel | None | None | 0 | 3 | 1 | 3 | View |
| rhNGF 20 µg/mL Part A | 3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 20 µg/mL Part A | None | None | 0 | 6 | 1 | 6 | View |
| rhNGF 60 µg/mL Part A | 3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 60 µg/mL Part A | None | None | 0 | 6 | 0 | 6 | View |
| rhNGF 0.5 µg/mL Sentinel | 1 x 35 µL drop 3 subjects rhNGF 0.5 µg/mL Sentinel: one drop administration | None | None | 0 | 3 | 0 | 3 | View |
| rhNGF 20 µg/mL Sentinel | 1 x 35 µL drop 3 subjects rhNGF 20 µg/mL Sentinel | None | None | 0 | 3 | 1 | 3 | View |
| rhNGF 180 µg/mL Part A | 3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 180 µg/mL Part A | None | None | 0 | 7 | 2 | 7 | View |
| Placebo Part A | 3 x 35 µL drops applied at 4 h intervals 6 subjects Placebo Part A | None | None | 0 | 6 | 3 | 6 | View |
| rhNGF 20 µg/mL Part B | 3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 12 subject rhNGF 20 µg/mL Part B | None | None | 0 | 12 | 8 | 12 | View |
| rhNGF 60 µg/mL Part B | 3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects rhNGF 60 µg/mL Part B | None | None | 0 | 9 | 6 | 9 | View |
| rhNGF 180 µg/mL Part B | 3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects rhNGF 180 µg/mL Part B | None | None | 0 | 9 | 7 | 9 | View |
| Placebo Part B | 3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 10 subjects Placebo Part B | None | None | 0 | 10 | 6 | 10 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Catheter site related reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Corneal staining | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Orapharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Abnormals sensation in eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Eyelid irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Eye discharge | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Eye swelling | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Joint stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Muscle twitching | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Vessel puncture site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |