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The purpose of this study is to assess the tolerability and safety of HKI-272, and to determine the maximum dose that can safety be given. The secondary purpose of this study is to determine how the body uses and gets rid of HKI-272 and to assess whether HKI-272 is effective for the treatment of advanced solid tumors.
This is a phase 1 open-label sequential-group study of ascending single and multiple oral doses administered to subjects with advanced solid tumors. Each subject will participate in only 1 dose group and will receive a single dose of test article, followed by a 1-week observation period, and then will receive the test article administered once-daily by mouth in cycles consisting of 28 days. Subjects will be enrolled in groups of 3 to 6. Adverse events and dose-limiting toxicities will be assessed from the first single dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neratinib 80 mg | Experimental |
| |
| Neratinib 160 mg | Experimental |
| |
| Neratinib 240 mg | Experimental |
| |
| Neratinib 320 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neratinib | Drug | HKI-272 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | DLT was defined as any drug-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, except the grade 3 nausea, vomiting, diarrhea, or rash, unless the subject was receiving appropriate medical therapy. Additional DLTs included the following: grade 2 or 3 diarrhea lasting 2 or more days for which the subject was receiving medical therapy or that was associated with fever or dehydration. | First dose date through 21 days |
| Maximum Tolerated Dose (MTD) | MTD is defined as the prior dose level of the dose level which has >=2 of 3 to 6 subjects that experience a neratinib-related DLT during 21 days from first dose date. A DLT is defined as any HKI-272-related nonhematologic grade 3 or any grade 4 AE according to the Common Terminology Criteria for Adverse Events version 3.0 except: Grade 3 nausea, vomiting, diarrhea, or rash unless subject was receiving appropriate medical therapy. | First dose date through 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the proportion of subjects who had either a complete response (CR) or partial response (PR), according to a modified Response Evaluation Criteria in Solid Tumors (RECIST). The modified RECIST is defined as CR: Disappearance of all target lesions, PR: At least a 30% decrease in the sum of the Longest Diameters (LDs) of target lesions, taking as reference the baseline sum LDs. Response required confirmation. |
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Inclusion criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Puma | Biotechnology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto | Tokyo | 135-8550 | Japan | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22371427 | Derived | Ito Y, Suenaga M, Hatake K, Takahashi S, Yokoyama M, Onozawa Y, Yamazaki K, Hironaka S, Hashigami K, Hasegawa H, Takenaka N, Boku N. Safety, efficacy and pharmacokinetics of neratinib (HKI-272) in Japanese patients with advanced solid tumors: a Phase 1 dose-escalation study. Jpn J Clin Oncol. 2012 Apr;42(4):278-86. doi: 10.1093/jjco/hys012. Epub 2012 Feb 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neratinib 80 mg | Neratinib 80 mg qd |
| FG001 | Neratinib 160 mg | Neratinib 160 mg qd |
| FG002 | Neratinib 240 mg | Neratinib 240 mg qd |
| FG003 | Neratinib 320 mg | Neratinib 320 mg qd |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Neratinib 80 mg | Neratinib 80 mg qd |
| BG001 | Neratinib 160 mg | Neratinib 160 mg qd |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dose Limiting Toxicity (DLT) | DLT was defined as any drug-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, except the grade 3 nausea, vomiting, diarrhea, or rash, unless the subject was receiving appropriate medical therapy. Additional DLTs included the following: grade 2 or 3 diarrhea lasting 2 or more days for which the subject was receiving medical therapy or that was associated with fever or dehydration. | All subjects who received at least one dose. | Posted | Count of Participants | Participants | First dose date through 21 days |
|
From first dose to 28 days after last dose, up to 9.2 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neratinib 80 mg | Neratinib 80 mg qd |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Operations | Puma Biotechnology, Inc. | +1 (424) 248-6500 | clinicaltrials@pumabiotechnology.com |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C487932 | neratinib |
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This was an open-label, phase 1, ascending single and multiple oral dose study of neratinib administered to subjects with advanced solid tumors. Each subject participated in only 1 dose group and received a single dose of neratinib. This was followed by a 1-week observation period, and the subject then received neratinib administered as a continual oral daily dose for up to 6 months (6 cycles). Daily dose administration could continue beyond 6 cycles at the same dose level after consultation with the sponsor if neratinib was well tolerated and there was no evidence of progressive disease.
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| From first dose date to disease progression or last tumor assessment, up to 9.2 months |
| Clinical Benefit Rate | Subjects with confirmed Complete Response (CR) or confirmed Partial Response (PR), or Stable Disease (SD) >= 24 weeks, according to a modified Response Evaluation Criteria in Solid Tumors (RECIST). SD is defined as SD in target lesions and a non-progressive disease (PD) in nontarget lesions; A PR is defined as either a PR in target lesions and a non-PD in nontarget lesions, or a CR in target lesions and an incomplete response or SD in nontarget lesions; and a CR is defined as a CR in target lesions and a CR in nontarget lesions. | From first dose date to progression/death or last assessment, up to 9.2 months. |
| Shizuoka Cancer Center |
| Shizuoka |
| 1411-8777 |
| Japan |
| BG002 |
| Neratinib 240 mg |
Neratinib 240 mg qd |
| BG003 | Neratinib 320 mg | Neratinib 320 mg qd |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Neratinib 160 mg qd |
| OG002 | Neratinib 240 mg | Neratinib 240 mg qd |
| OG003 | Neratinib 320 mg | Neratinib 320 mg qd |
|
|
| Secondary | Objective Response Rate (ORR) | ORR is defined as the proportion of subjects who had either a complete response (CR) or partial response (PR), according to a modified Response Evaluation Criteria in Solid Tumors (RECIST). The modified RECIST is defined as CR: Disappearance of all target lesions, PR: At least a 30% decrease in the sum of the Longest Diameters (LDs) of target lesions, taking as reference the baseline sum LDs. Response required confirmation. | Subjects who received at least 14 days of continual dose administration of drug and who had undergone at least 1 follow-up tumor assessment were considered evaluable for efficacy | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose date to disease progression or last tumor assessment, up to 9.2 months |
|
|
|
| Secondary | Clinical Benefit Rate | Subjects with confirmed Complete Response (CR) or confirmed Partial Response (PR), or Stable Disease (SD) >= 24 weeks, according to a modified Response Evaluation Criteria in Solid Tumors (RECIST). SD is defined as SD in target lesions and a non-progressive disease (PD) in nontarget lesions; A PR is defined as either a PR in target lesions and a non-PD in nontarget lesions, or a CR in target lesions and an incomplete response or SD in nontarget lesions; and a CR is defined as a CR in target lesions and a CR in nontarget lesions. | Subjects who received at least 14 days of continual dose administration of drug and who had undergone at least 1 follow-up tumor assessment were considered evaluable for efficacy | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose date to progression/death or last assessment, up to 9.2 months. |
|
|
|
| Primary | Maximum Tolerated Dose (MTD) | MTD is defined as the prior dose level of the dose level which has >=2 of 3 to 6 subjects that experience a neratinib-related DLT during 21 days from first dose date. A DLT is defined as any HKI-272-related nonhematologic grade 3 or any grade 4 AE according to the Common Terminology Criteria for Adverse Events version 3.0 except: Grade 3 nausea, vomiting, diarrhea, or rash unless subject was receiving appropriate medical therapy. | All subjects who received at least one dose. | Posted | Number | mg | First dose date through 21 days |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Neratinib 160 mg | Neratinib 160 mg qd | 0 | 3 | 3 | 3 |
| EG002 | Neratinib 240 mg | Neratinib 240 mg qd | 4 | 10 | 10 | 10 |
| EG003 | Neratinib 320 mg | Neratinib 320 mg qd | 2 | 5 | 5 | 5 |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (17.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (17.0) | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Meibomian gland dysfunction | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Trichiasis | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Gastric varices | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Tongue discolouration | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Tooth discolouration | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hepatic haemorrhage | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Gingival abscess | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Proctitis infectious | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Chemical peritonitis | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood calcium increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood cholesterol decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood creatinine decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Monocyte count increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Haemoglobinuria | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hangnail | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
Not provided