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 @ 5:15 PM
Ignite Modification Date:
2025-12-25 @ 2:53 PM
NCT ID:
NCT05147350
Description:
None
Frequency Threshold:
5
Time Frame:
Start of treatment to 30 days post last dose. up to 1.5 years
Study:
NCT05147350
Study Brief:
Study of RP-6306 With FOLFIRI in Advanced 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 |
|---|---|---|---|---|---|---|---|---|
| 40 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI | 40 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle | 2 | None | 1 | 2 | 2 | 2 | View |
| 120 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI | 120 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle | 3 | None | 2 | 3 | 3 | 3 | View |
| 180 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI | 180 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle | 3 | None | 5 | 9 | 9 | 9 | View |
| 240 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI | 240 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle | 2 | None | 3 | 4 | 4 | 4 | View |
| 60 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI | 60 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle | 2 | None | 3 | 7 | 7 | 7 | View |
| 80 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI | 80 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle | 1 | None | 1 | 3 | 3 | 3 | View |
| 80 mg BID RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI | 80 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle | 1 | None | 2 | 4 | 4 | 4 | View |
| 120 mg QD RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI | 120 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle | 3 | None | 2 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Rectal Hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Small Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Abdominal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Biliary infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Clostridium Difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Blood bilirubin | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypophosphatamia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Acute Kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Dry Eye | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomitting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Candida infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| SAR-COV-2 test positive | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyponatramia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Cachexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Taste Disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Reproductive system and breast disorder | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| palmar-plantar Erythrodysaesthesia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| skin discoloration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| dyspnea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |