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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
NCT ID:
NCT03332667
Description:
Adverse events were collected through regular investigator assessment and regular laboratory testing.
Frequency Threshold:
5
Time Frame:
All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Study:
NCT03332667
Study Brief:
MIBG With Dinutuximab +/- Vorinostat
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 A DL1 | Patients will receive 131I-MIBG on day 1 at 12mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy. | 4 | None | 3 | 6 | 6 | 6 | View |
| Cohort A DL3 | Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy. | 12 | None | 6 | 20 | 19 | 20 | View |
| Cohort B DL4 | Vorinostat will be given on days 0-13 at 180mg/m2/dose. Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy. | 5 | None | 8 | 14 | 14 | 14 | View |
| Cohort A DL2 | Patients will receive 131I-MIBG on day 1 at 15mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy. | 1 | None | 2 | 5 | 5 | 5 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Jejunal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Allergic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAEV5.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV5.0 | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV5.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV5.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV5.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEV5.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEV5.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV5.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV5.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAEV5.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV5.0 | View |
| Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAEV5.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEV5.0 | View |
| Urinary tract pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEV5.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEV5.0 | View |
| BLEEDING | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEV5.0 | View |
| Eosinophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEV5.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEV5.0 | View |
| Methemoglobinemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEV5.0 | View |
| GALLOP RHYTHM | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEV5.0 | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEV5.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEV5.0 | View |
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAEV5.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAEV5.0 | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEV5.0 | View |
| Periorbital edema | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEV5.0 | View |
| REDNESS | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEV5.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| ORAL THRUSH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Salivary duct inflammation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Stomach pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV5.0 | View |
| Disease Progression | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV5.0 | View |
| Edema face | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV5.0 | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV5.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV5.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV5.0 | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV5.0 | View |
| Generalized edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV5.0 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV5.0 | View |
| Localized edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV5.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV5.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV5.0 | View |
| Allergic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAEV5.0 | View |
| Anaphylaxis | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAEV5.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV5.0 | View |
| Conjunctivities | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV5.0 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV5.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV5.0 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV5.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV5.0 | View |
| Rhinitis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV5.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV5.0 | View |
| Thrush | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV5.0 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV5.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV5.0 | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAEV5.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAEV5.0 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Blood bicarbonate decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Electrocardiogram QT corrected interval prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| GGT increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Hemoglobin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| INR increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Thyroid stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV5.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Hyperphosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV5.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV5.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV5.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV5.0 | View |
| JAW PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV5.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV5.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV5.0 | View |
| Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAEV5.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV5.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV5.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV5.0 | View |
| Hypersomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV5.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV5.0 | View |
| Movements involuntary | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV5.0 | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV5.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV5.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV5.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV5.0 | View |
| Spasticity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV5.0 | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV5.0 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEV5.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEV5.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEV5.0 | View |
| Hallucinations | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEV5.0 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEV5.0 | View |
| Bladder spasm | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEV5.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEV5.0 | View |
| FOLEY PAIN | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEV5.0 | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEV5.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEV5.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEV5.0 | View |
| Penile pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAEV5.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV5.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV5.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV5.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV5.0 | View |
| Postnasal drip | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV5.0 | View |
| RHINOVIRUS OR ENTEROVIRUS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV5.0 | View |
| Rhinorrhea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV5.0 | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV5.0 | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV5.0 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV5.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV5.0 | View |
| DIAPER RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV5.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV5.0 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV5.0 | View |
| IRRITATION AT PORT SITE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV5.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV5.0 | View |
| REDNESS FROM RUBBING | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV5.0 | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV5.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV5.0 | View |
| UNSPECIFIED NON-PRURITIC RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV5.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV5.0 | View |
| Capillary leak syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEV5.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEV5.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEV5.0 | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEV5.0 | View |
| EYE DISCHARGE | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEV5.0 | View |
| EYE ITCHINESS | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEV5.0 | View |
| Facial pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV5.0 | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV5.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV5.0 | View |
| PERINEUM REDNESS & ITCHSING | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV5.0 | View |
| Pain of skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV5.0 | View |