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 @ 2:27 AM
Ignite Modification Date:
2025-12-26 @ 1:01 AM
NCT ID:
NCT04103034
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse events were collected from time of screening up to 56 days post dose
Study:
NCT04103034
Study Brief:
A SAD/MAD Study of Safety, Tolerability and Pharmacologic Activity of BT200 in Normal 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 |
|---|---|---|---|---|---|---|---|---|
| BT200 0.18mg | Subjects will receive a single subcutaneous dose of BT200 0.18mg BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 0 | None | 0 | 6 | 4 | 6 | View |
| BT200 0.6mg | Subjects will receive a single subcutaneous dose of BT200 0.6mg BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 0 | None | 0 | 6 | 3 | 6 | View |
| BT200 1.8mg | Subjects will receive a single subcutaneous dose of BT200 1.8mg BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 0 | None | 0 | 6 | 4 | 6 | View |
| BT200 24.0mg | Subjects will receive a single subcutaneous dose of BT200 24.0mg BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 0 | None | 0 | 6 | 6 | 6 | View |
| BT200 24.0mg Rep | Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 0 | None | 1 | 6 | 5 | 6 | View |
| BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg | Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 0 | None | 0 | 6 | 6 | 6 | View |
| BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg | Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 0 | None | 1 | 6 | 6 | 6 | View |
| Placebo MAD | Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo Placebo: Sterile saline for injection | 0 | None | 0 | 4 | 4 | 4 | View |
| Placebo + Desmopressin Challenge Dose | Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo BT200: BT200 is a PEGylated synthetic RNA oligonucleotide Desmopressin: Sterile solution for injection | 0 | None | 0 | 2 | 1 | 2 | View |
| Placebo Infusion | Subjects will receive a single IV dose of placebo administered over 24 hours Placebo: Sterile saline for injection | 0 | None | 0 | 2 | 1 | 2 | View |
| BT200 48.0 mg | Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 0 | None | 1 | 6 | 4 | 6 | View |
| BT200 24mg IV Infusion | Subjects will receive a single IV dose of BT200 24mg administered over 24 hours | 0 | None | 0 | 6 | 4 | 6 | View |
| BT200 6.0mg | Subjects will receive a single subcutaneous dose of BT200 6.0mg BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 0 | None | 0 | 6 | 4 | 6 | View |
| BT200 12.0mg | Subjects will receive a single subcutaneous dose of BT200 12.0mg BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 0 | None | 0 | 6 | 5 | 6 | View |
| Placebo SAD | Subjects will receive a single subcutaneous dose of placebo Placebo: Sterile saline for injection | 0 | None | 1 | 20 | 16 | 20 | View |
| BT200 48.0mg + Desmopressin Challenge | Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200 BT200: BT200 is a PEGylated synthetic RNA oligonucleotide Desmopressin: Sterile solution for injection | 0 | None | 0 | 6 | 5 | 6 | View |
| BT200 36.0mg | Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 0 | None | 0 | 6 | 4 | 6 | View |
| BT200 18.0 mg | Subjects will receive a single subcutaneous dose of BT200 18.o mg | 0 | None | 0 | 6 | 5 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Infected dermal cyst | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Root canal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Motor dysfunction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Abdominal pain uppe | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Rash Maculopapular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Alcohol poisoning | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Subcutaneous Hematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.1 | View |
| Gammaglutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Transaminase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Folate deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Gynecomastia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.1 | View |
| Parasthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Venous thrombosis limb | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Tenderness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Hemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Skin discoloration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 23.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Axillary pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Vessel puncture site hematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Gingival bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Hemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |