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 @ 4:38 AM
Ignite Modification Date:
2025-12-26 @ 3:39 AM
NCT ID:
NCT02810418
Description:
None
Frequency Threshold:
0
Time Frame:
Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
Study:
NCT02810418
Study Brief:
Mesothelin-Targeted Immunotoxin LMB-100 Alone or in Combination With Nab-Paclitaxel in People With Previously Treated Metastatic and/or Locally Advanced Pancreatic Ductal Adenocarcinoma and Mesothelin Expressing Solid Tumors
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 A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100 | Arm A1, DL1, Ph I Short Infusion 100µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles | 5 | None | 3 | 6 | 6 | 6 | View |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles | 8 | None | 4 | 8 | 8 | 8 | View |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles | 5 | None | 1 | 6 | 6 | 6 | View |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in 10 | Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion. | 6 | None | 2 | 6 | 6 | 6 | View |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles | 3 | None | 2 | 3 | 3 | 3 | View |
| Arm B1,Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion. | 6 | None | 2 | 6 | 6 | 6 | View |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles. | 3 | None | 1 | 5 | 5 | 5 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Capillary leak syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Colonic perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Left ventricular systolic dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Localized edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Lower gastrointestinal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, death | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, pancreatic cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, died at home | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Peritoneal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Right ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Upper gastrointestinal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Respiratory, thoracic and mediastinal disorders - Other, tachypnea intermittent | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Right ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Skin and subcutaneous tissue disorders - Other, buttock excoriation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Skin ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Urine output decreased | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |