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 @ 5:58 PM
Ignite Modification Date:
2025-12-25 @ 3:21 PM
NCT ID:
NCT04287868
Description:
1/48 participants in cohort 1 was a screening fail.
Frequency Threshold:
0
Time Frame:
Date treatment consent signed to date off study, approximately 34 months and 20 days.
Study:
NCT04287868
Study Brief:
Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies | Cohort 1, Arm 1, Treatment Assignment Code (TAC) 1: Participants with HPV associated malignancies will receive human papillomavirus (HPV) vaccine every (q) 4 weeks x6, then q3 months (MO) x2 + NHS-IL12 q 4 weeks (wks) + M7824 q 2 wks. PDS0101 will be administered on Day (D)1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. Subcutaneous 1.0mL (2.4mg of total peptide and 3 mg of R-DOTAP (Versamune) injection). M7824 will be administered at a flat dose of 1,200 mg intravenous (IV) (over 1 hour) once every 2 weeks. NHS-IL12 will be administered by subcutaneous (SC) injection every 4 weeks. | 28 | None | 18 | 47 | 47 | 47 | View |
| Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy | Cohort 2, Arm 2, Treatment Assignment Code (TAC) 1: Participants with cervical cancer with prior pelvic radiation and boost brachytherapy will receive human papillomavirus (HPV) vaccine + NHS-IL12 + M7824 (MSB0011359C) at reduced doses. PDS0101 will be administered on Day (D)1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. Subcutaneous 1.0mL (2.4mg of total peptide and 3 mg of R-DOTAP (Versamune) injection). M7824 will be administered at a flat dose of 1,200 mg intravenous (IV) (over 1 hour) once every 2 weeks. NHS-IL12 will be administered by subcutaneous (SC) injection every 4 weeks. | 0 | None | 1 | 3 | 3 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Cardiac disorders - Other, Immune mediated myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Duodenal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Gastric hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Gastroparesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Hematuria | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, MUCOSAL BLEEDING, VAGINAL HEMORRHAGE; | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Mucosal bleeding | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Mucosal bleeding (anal bleeding) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Mucosal bleeding, vaginal | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Mucosal bleeding-Hematuria | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Immune system disorders - Other, Hemophagocytic Lymphohistiocytosis | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (5.0) | View |
| Infections and infestations - Other, COVID | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Edema face | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Electrocardiogram QT corrected interval prolonged | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Erectile dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (5.0) | View |
| Esophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Eye disorders - Other, (left eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Eye disorders - Other, left eye stye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Eye infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Facial nerve disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| GGT increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Gastrointestinal disorders - Other, Gastrointestinal disorders - blood in stool | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Gastrointestinal disorders - Other, blood noted in stool | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, anal hemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, anal bleeding | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, bleeding from tumor sites | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Hyperphosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (5.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Bloating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| CPK increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Cardiac disorders - Other, Immune mediated myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Cardiac troponin I increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Cholesterol high | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, intermittent rectal bleeding | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Gum infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Hyperkeratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (5.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| INR increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Infections and infestations - Other, COVID | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - Other, COVID-19 positive | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - Other, Staph Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - Other, at PEG site | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - Other, AAA noted on BL CT | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Investigations - Other, AAA noted on BL CT | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Investigations - Other, CRP Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Investigations - Other, Elevated Hgb A1C | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Investigations - Other, Low iron levels | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Investigations - Other, Oral lesion | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Investigations - Other, elevated troponin | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Laryngeal hemorrhage | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Laryngeal inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Lymph node pain | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Lymphedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Muscle cramp | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Muscle weakness lower limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Muscle weakness upper limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Musculoskeletal and connective tissue disorder - Other, RLE foot drop | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Myositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Polyps | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Nervous system disorders - Other, (expressive aphasia) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Nervous system disorders - Other, Facial tingling | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Non cardiac chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Oral hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Osteonecrosis of jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Papulopustular rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Periodontal disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Postoperative hemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Radiation recall reaction (dermatologic) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Rash - Eruptive Keratoacanthomas | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Rectal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Rectal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Renal and urinary disorders - Other, Asymptomatic bacteremia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Renal and urinary disorders - Other, urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Respiratory, thoracic and mediastinal disorders - Other, SARS-CoV-2 infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Rhinorrhea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Serum amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, Basal Cell Carcinoma (cheek) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, Bruise to R Shin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, Dermatitis,bilateral forearms | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, Diaphoresis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, Diaphoretic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, Inguinal pimple | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, KA's back, legs, neck | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, KA's various parts of the body | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, Keratoacanthoma | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, Keratoacanthoma nose/hands | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, Neck lesion/mass, outside records | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, R elbow/arm rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, Seborrheic dermatitis, scalp & beard | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, itchy blemish on skin of back | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, papule upper, inner right arm | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other, rash multiple sites | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin papilloma | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Soft tissue infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Stoma site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Stomach pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Superficial thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Superior vena cava syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Surgical and medical procedures - Other, (left VATS lower lobe wedge resection x2) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (5.0) | View |
| Surgical and medical procedures - Other, (right VATS lower lobectomy) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (5.0) | View |
| Surgical and medical procedures - Other, Bifrontal Craniotomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (5.0) | View |
| Surgical and medical procedures - Other, Cardiac cath | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (5.0) | View |
| Surgical and medical procedures - Other, Hemorrhoidectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (5.0) | View |
| Surgical and medical procedures - Other, Upper abdomen midline surgical incision | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (5.0) | View |
| Surgical and medical procedures - Other, right VATS | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (5.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Testicular disorder | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (5.0) | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Thrush | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Thyroid stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (5.0) | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (5.0) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Tumor hemorrhage | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Upper gastrointestinal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (5.0) | View |
| Vaginal hemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (5.0) | View |
| Vaginal pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (5.0) | View |
| Vascular disorders - Other, Bil PE | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Vascular disorders - Other, livedo reticularis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (5.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Allergic rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Anal fissure | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Anal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Anal mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Arterial thromboembolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, (mucosal bleeding): Hematuria | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Bleeding gums when brushing teeth | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Dyschezia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Epistaxis | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Gum Bleeding | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Gum bleeding w/ dental procedure | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Hematuria | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Mucosal Bleeding - "Bloody BM" | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Mucosal Bleeding - Gingival | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Mucosal Bleeding - Hematuria | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Mucosal Bleeding - TRACH secretions | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Mucosal Hemorrhage - Hemoptysis | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Mucosal bleeding | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Mucosal bleeding - Epistaxis | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Mucosal bleeding-Hematochezia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Rectal Bleeding | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, TRACH secretion | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, Vaginal bleeding | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, epistaxis | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, intermittent gum bleeding | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| General disorders and administration site conditions - Other, intermittent gum bleeding w/flossing | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |