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 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
NCT ID:
NCT03448393
Description:
16/54 participants were not treated.
Frequency Threshold:
0
Time Frame:
All-Cause Mortality was monitored/assessed an average of 35 days. Adverse Events were monitored/assessed from the first study intervention (Study Day -4, through day 30 after the study agent (s) was/were administered) in any cycle, an average of 5 weeks.
Study:
NCT03448393
Study Brief:
CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell 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 |
|---|---|---|---|---|---|---|---|---|
| GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide. Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 25 mg/m\^2/dose on Day -4, -3, -2. Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 900 mg/m\^2/dose after fludarabine infusion on Day -2. Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells Dose Level 1, 3 x10\^5 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 4 | None | 2 | 4 | 4 | 4 | View |
| GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Participants who previously received Chimeric Antigen Receptor (CAR) therapy. Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide. Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 30 mg/m\^2/dose on Day -5, -4, -3, -2. Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 600 mg/m\^2/dose after fludarabine infusion on Day -3 \& -2. Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at Dose Level 3, 3 x10\^6 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 0 | None | 1 | 1 | 1 | 1 | View |
| GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Participants who are chimeric antigen receptor (CAR) naïve or CAR pre-treated and received an interval transplant. Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide. Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 25 mg/m\^2/dose on Day -4, -3, -2. Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 900 mg/m\^2/dose after fludarabine infusion on Day -2. Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at Dose Level 3, 3 x10\^6 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 8 | None | 7 | 21 | 21 | 21 | View |
| GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Participants who previously received Chimeric Antigen Receptor (CAR) therapy. Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide. Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 30 mg/m\^2/dose on Day -5, -4, -3, -2. Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 600 mg/m\^2/dose after fludarabine infusion on Day -3 \& -2. Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at Dose Level 3, 3 x10\^6 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 1 | None | 0 | 1 | 1 | 1 | View |
| Group 8:Cohort 2C, CAR Naïve or CAR Pretreated With Previous Hematopoietic Stem Cell Transplantation | Participants with isolated central nervous system (CNS) disease. Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide. Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 25 mg/m\^2/dose on Day -4, -3, -2. Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 900 mg/m\^2/dose after fludarabine infusion on Day -2. Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at Dose Level 3, 3 x10\^6 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 0 | None | 1 | 1 | 1 | 1 | View |
| GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide. Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 25 mg/m\^2/dose on Day -4, -3, -2. Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 900 mg/m\^2/dose after fludarabine infusion on Day -2. Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at Dose Level 2, 1x10\^6 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 3 | None | 2 | 4 | 4 | 4 | View |
| GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide. Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 25 mg/m\^2/dose on Day -4, -3, -2. Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 900 mg/m\^2/dose after fludarabine infusion on Day -2. Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at Dose Level 3, 3 x10\^6 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 2 | None | 0 | 4 | 4 | 4 | View |
| GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Participants who are chimeric antigen receptor (CAR) naïve or CAR pre-treated and received an interval transplant. Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide. Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 25 mg/m\^2/dose on Day -4, -3, -2. Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 900 mg/m\^2/dose after fludarabine infusion on Day -2. Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at Dose Level 3, 3 x10\^6 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen. | 2 | None | 2 | 2 | 2 | 2 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Cytokine release syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (5.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| GGT increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Gastric hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Immune system disorders - Other, GVHD | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (5.0) | View |
| Infections and infestations - Other, COVID-19(omicron strain is >90%) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Nervous system disorders - Other, (Neurotoxicity) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Nervous system disorders - Other, ICANS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Nervous system disorders - Other, ICANS level grade 3 CTCAE v5 grade 3 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 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 |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (5.0) | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric 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 |
| Allergic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | 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 pain | 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 |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 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 |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal 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 and lymphatic system disorders - Other, specify: Inguinal lymph node enlarged on L | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Blood bicarbonate decreased | SYSTEMATIC_ASSESSMENT | Investigations | 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 |
| Blood prolactin abnormal | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Breast pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (5.0) | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Bullous dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| CPK increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Cardiac disorders - Other, specify: Grade II/VI systolic ejection murmur at LSB | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Cardiac disorders - Other, specify: Hypokinesia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Cardiac troponin I increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Chest pain - cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue 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 |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 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 |
| Cushingoid | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (5.0) | View |
| Cytokine release syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (5.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Depression | 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 mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dysphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth 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 |
| Edema trunk | 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 |
| Eye disorders - Other, specify: Irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Eye disorders - Other, specify: Right visual field cut, | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Eye disorders - Other, specify: corneal abrasion | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Facial pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Fecal incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Fibrinogen decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| GGT increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Gastrointestinal disorders - Other, specify: Mucosal colored protrusion in mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Generalized edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Glucosuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Haptoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Hemolysis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Hepatobiliary disorders - Other, specify: Gallbladder wall/periportal edema | SYSTEMATIC_ASSESSMENT | Hepatobiliary 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 |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition 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 |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hyperuricemia | 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 |
| Hypothermia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| INR increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Infections and infestations - Other, specify: Bacteroides fragilis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - Other, specify: C.difficile | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - Other, specify: CMV | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - Other, specify: COVID | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - Other, specify: Coronavirus | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - Other, specify: HSV | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - Other, specify: Norovirus | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - Other, specify: Rhino/enterovirus | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - Other, specify: Staph blepharitis Rt Eye (Ophth note) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - Other, specify: Staphylococcus epidermidis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - Other, specify: gram negative rod (E. Coli) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Localized edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Movements involuntary | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Muscle weakness lower limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Musculoskeletal and connective tissue disorder - Other, specify: Wrist joint stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Myalgia | 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 |
| Neck edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Neuralgia | 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 |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal 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 |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 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 sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Photosensitivity | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue 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 |
| Postnasal drip | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Rectal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Rectal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Respiratory, thoracic and mediastinal disorders - Other, specify: Lung nodule | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Rhinorrhea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Scrotal pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (5.0) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Sinus pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Skin hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 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 |
| Stomach pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Tendon reflex decreased | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Wound complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Gastric hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Flu-like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Immune system disorders, other GVHD | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (5.0) | View |