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 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:48 AM
NCT ID:
NCT01958060
Description:
None
Frequency Threshold:
5
Time Frame:
from the first drug administration to end of trial, up to 50 days
Study:
NCT01958060
Study Brief:
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Single Escalating Doses of BI 1034020 Administered Intravenously or Subcutaneously to Male 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 |
|---|---|---|---|---|---|---|---|---|
| BI 1034020 (5 mg/25 mL - iv) | Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. | None | None | 0 | 6 | 3 | 6 | View |
| BI 1034020 (10 mg/25 mL - iv) | Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. | None | None | 0 | 6 | 4 | 6 | View |
| BI 1034020 (20 mg/25 mL - iv) | Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. | None | None | 0 | 5 | 3 | 5 | View |
| BI 1034020 (50 mg/25 mL - iv) | Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. | None | None | 0 | 6 | 5 | 6 | View |
| BI 1034020 (100 mg/25 mL - iv) | Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. | None | None | 1 | 1 | 1 | 1 | View |
| Placebo | Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning. | None | None | 0 | 8 | 6 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaphylactoid reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MEDDRA 17.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 17.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 17.0 | View |
| Photopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 17.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Faeces discoloured | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Injection site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MEDDRA 17.0 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MEDDRA 17.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 17.0 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 17.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 17.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 17.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | View |
| Skin irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 17.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 17.0 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 17.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | View |