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 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
NCT ID:
NCT04107805
Description:
Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Frequency Threshold:
5
Time Frame:
Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days.
Study:
NCT04107805
Study Brief:
A Study in Healthy Men and Women to Test How Well Different Doses of BI 1323495 Are Tolerated
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/Placebo + Midazolam | This arm comprises placebo only treated participants and those participants who received placebo + midazolam. Placebo only treated participants were administered film-coated tablets of placebo matching BI 1323495 dosage and participants who received placebo + midazolam were administered film-coated tablets of placebo matching BI 1323495 dosage + a single daily dose of 1.5 milliliter (mL) of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast on Day -1 and on Day 11. | 0 | None | 0 | 22 | 9 | 22 | View |
| Midazolam Alone | This arm consisted of all participants of the arms "70 mg BI 1323495 bid + Midazolam EM", "120 mg BI 1323495 bid + Midazolam EM", "150 mg BI 1323495 bid + Midazolam EM" and 9 subjects of the arm "Placebo/Placebo + Midazolam" which were administered midazolam on Day -1 of the trial. The duration of this analysis phase was approximately 1 day (from Day -1 to first administration of BI 1323495 on Day 1). | 0 | None | 0 | 36 | 2 | 36 | View |
| 10 mg BI 1323495 Bid EM | Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. | 0 | None | 0 | 9 | 6 | 9 | View |
| 10 mg BI 1323495 Bid PM | Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. | 0 | None | 0 | 5 | 3 | 5 | View |
| 30 mg BI 1323495 Bid EM | Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage=30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. | 0 | None | 0 | 9 | 8 | 9 | View |
| 30 mg BI 1323495 Bid PM | Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage = 30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. | 0 | None | 0 | 6 | 4 | 6 | View |
| 70 mg BI 1323495 Bid + Midazolam EM | Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and one film-coated tablet of 50 mg of BI 1323495 (total dosage=70 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single dose of 1.5 ml of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast. | 0 | None | 0 | 9 | 6 | 9 | View |
| 120 mg BI 1323495 Bid + Midazolam EM | Participants with at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast. | 0 | None | 0 | 9 | 4 | 9 | View |
| 120 mg BI 1323495 qd EM | Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. | 0 | None | 0 | 9 | 6 | 9 | View |
| 150 mg BI 1323495 Bid + Midazolam EM | Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 150 milligram (mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast. | 0 | None | 0 | 9 | 6 | 9 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Head discomfort | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Restless legs syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Tension headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Electrocardiogram PR shortened | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Electrocardiogram QT prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Solar urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Bradyphrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 23.1 | View |
| Ear discomfort | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 23.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Tendon pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.1 | View |
| Food allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 23.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Laziness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.1 | View |
| Hyperarousal | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.1 | View |
| Tension | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |