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 @ 2:03 PM
Ignite Modification Date:
2025-12-25 @ 12:47 PM
NCT ID:
NCT01791595
Description:
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
Frequency Threshold:
0
Time Frame:
Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
Study:
NCT01791595
Study Brief:
A Phase I Trial of AZD3965 in Patients With Advanced Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| AZD3965 Cohort 1 (5 mg OD) | AZD3965: Day -7: single dose of 5 mg AZD3965 orally prior to start of continuous treatment. Cycle 1, Day 1: commenced dosing of 5 mg AZD3965 OD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor. | 1 | None | 1 | 3 | 3 | 3 | View |
| AZD3965 Cohort 2 (10 mg OD) | AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment. Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor. | 1 | None | 1 | 5 | 5 | 5 | View |
| AZD3965 Cohort 3 (20 mg OD) | AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment. Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor. | 0 | None | 3 | 8 | 7 | 8 | View |
| AZD3965 Cohort 4 (30 mg OD) | AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment. Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor. | 0 | None | 2 | 5 | 5 | 5 | View |
| AZD3965 Cohort 5 (15 mg BD) | AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment. Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor. | 0 | None | 8 | 11 | 11 | 11 | View |
| AZD3965 Cohort 6 (10 mg BD) | AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment. Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor. | 0 | None | 4 | 8 | 7 | 8 | View |
| AZD3965 Expansion Cohort (10 mg BD) | AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1). Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles. Patients benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor. | 0 | None | 8 | 11 | 11 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Accidental overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE4.02/MedDRA23.0 | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE4.02/MedDRA23.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Cardiac troponin I increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Cardiac troponin T increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE4.02/MedDRA23.0 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE4.02/MedDRA23.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE4.02/MedDRA23.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Infections and infestations - Other, specify | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Infective exacerbation of bronchiectasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Myelodysplastic syndrome | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE4.02/MedDRA23.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Ophthalmic herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE4.02/MedDRA23.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE4.02/MedDRA23.0 | View |
| Renal and urinary disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE4.02/MedDRA23.0 | View |
| Retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Troponin I increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE4.02/MedDRA23.0 | View |
| Ulcer | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE4.02/MedDRA23.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE4.02/MedDRA23.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE4.02/MedDRA23.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE4.02/MedDRA23.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE4.02/MedDRA23.0 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE4.02/MedDRA23.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Balance disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE4.02/MedDRA23.0 | View |
| Blindness transient | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Bloating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Blood and lymphatic system disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE4.02/MedDRA23.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Cardiac troponin I increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Cardiac troponin T increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE4.02/MedDRA23.0 | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Concentration impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE4.02/MedDRA23.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Cyst | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Cystitis noninfective | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE4.02/MedDRA23.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE4.02/MedDRA23.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE4.02/MedDRA23.0 | View |
| Device occlusion | SYSTEMATIC_ASSESSMENT | Product Issues | CTCAE4.02/MedDRA23.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE4.02/MedDRA23.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE4.02/MedDRA23.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Dysphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE4.02/MedDRA23.0 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Enterovesical fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Esophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Eye disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Eye inflammation | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Facial pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Genitals enlarged | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE4.02/MedDRA23.0 | View |
| H3N2 influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE4.02/MedDRA23.0 | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE4.02/MedDRA23.0 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE4.02/MedDRA23.0 | View |
| Hoarseness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE4.02/MedDRA23.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Increased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Infections and infestations - Other, specify | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE4.02/MedDRA23.0 | View |
| Investigations - Other, specify | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Lip infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Metabolism and nutrition disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE4.02/MedDRA23.0 | View |
| Moraxella infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Movements involuntary | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE4.02/MedDRA23.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Nervous system disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE4.02/MedDRA23.0 | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE4.02/MedDRA23.0 | View |
| Nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE4.02/MedDRA23.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Optic nerve disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Oral hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE4.02/MedDRA23.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE4.02/MedDRA23.0 | View |
| Performance status decreased | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE4.02/MedDRA23.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Pseudomonas infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE4.02/MedDRA23.0 | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Respiratory, thoracic and mediastinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Retinal vascular disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Retinogram abnormal | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Rhinitis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE4.02/MedDRA23.0 | View |
| Skin and subcutaneous tissue disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE4.02/MedDRA23.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Urine discoloration | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE4.02/MedDRA23.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Watering eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE4.02/MedDRA23.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE4.02/MedDRA23.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE4.02/MedDRA23.0 | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE4.02/MedDRA23.0 | View |
| Candida infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE4.02/MedDRA23.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Injury, poisoning and procedural complications - Other, specify | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE4.02/MedDRA23.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE4.02/MedDRA23.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE4.02/MedDRA23.0 | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE4.02/MedDRA23.0 | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE4.02/MedDRA23.0 | View |
| Taste disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE4.02/MedDRA23.0 | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE4.02/MedDRA23.0 | View |