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 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
NCT ID:
NCT03884556
Description:
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
Frequency Threshold:
5
Time Frame:
Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Study:
NCT03884556
Study Brief:
TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm 1: TTX-030 0.5 mg/kg | Participants in Arm 1 Escalation were administered IV 0.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. | 0 | None | 0 | 1 | 1 | 1 | View |
| Arm 1: TTX-030 1.5 mg/kg | Participants in Arm 1 Escalation were administered IV 1.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. | 1 | None | 1 | 2 | 1 | 2 | View |
| Arm 1: TTX-030 3.0 mg/kg | Participants in Arm 1 Escalation were administered IV 3.0 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. | 1 | None | 1 | 2 | 2 | 2 | View |
| Arm 1: TTX-030 6.0 mg/kg | Participants in Arm 1 Escalation were administered IV 6.0 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. | 1 | None | 1 | 4 | 4 | 4 | View |
| Arm 1: TTX-030 10 mg/kg | Participants in Arm 1 Escalation were administered IV 10 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. | 1 | None | 1 | 3 | 3 | 3 | View |
| Arm 1: TTX-030 20 mg/kg | Participants in Arm 1 Escalation were administered IV 20 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. | 2 | None | 0 | 3 | 3 | 3 | View |
| Arm 1: TTX-030 40 mg/kg | Participants in Arm 1 Escalation were administered IV 40 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. | 3 | None | 4 | 6 | 3 | 6 | View |
| Arm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3W | Participants in Expansion received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W. | 1 | None | 2 | 8 | 6 | 8 | View |
| Arm 2 (Safety Lead-in and Expansion), Combination | Participants in Safety Lead-in portion and Expansion of Arm 2 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W and pembrolizumab IV at a dose of 200 mg on Day 1 of each 21-day treatment cycle. | 4 | None | 6 | 13 | 13 | 13 | View |
| Arm 4 (Safety Lead-In and Expansion) | Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m\^2 + nab-Paclitaxel 125 mg/m\^2 Days 1, 8, and 15 every 28 days. | 7 | None | 4 | 14 | 14 | 14 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Autoimmune hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v5.0 | View |
| Oesophageal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Generalized edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Hyperbilirubinemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v5.0 | View |
| Allergy to arthropod sting | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE v5.0 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Extradural abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v5.0 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v5.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v5.0 | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Obstructive airways disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v5.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v5.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v5.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v5.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Back pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v5.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Edema peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v5.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v5.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v5.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v5.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v5.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v5.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v5.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v5.0 | View |