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 @ 3:42 PM
Ignite Modification Date:
2025-12-25 @ 1:51 PM
NCT ID:
NCT02309892
Description:
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
Frequency Threshold:
0
Time Frame:
Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Study:
NCT02309892
Study Brief:
A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. | 3 | None | 0 | 3 | 3 | 3 | View |
| L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. | 2 | None | 3 | 6 | 6 | 6 | View |
| L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. | 0 | None | 0 | 1 | 1 | 1 | View |
| L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. | 1 | None | 1 | 1 | 1 | 1 | View |
| L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. | 1 | None | 1 | 2 | 2 | 2 | View |
| L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. | 1 | None | 1 | 1 | 1 | 1 | View |
| L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. | 0 | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| diarrhea | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| gastroesophageal reflux | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| hyperchlorhydria | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| rectal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| facial pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| weight fluctuation | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| dyslipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| increased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| malnutrition | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| hyperdrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| macule | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| rash generalized | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| white blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| pallor | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| superior vena cava syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| bone swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| viral upper respiratory infection | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (17.1) | View |
| haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (17.1) | View |
| defect conduction intraventricular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.1) | View |
| tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.1) | View |