Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01597258
Collaborator
(none)
2,029
69.6
Study Details
Study Description
Brief Summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.
Study Design
Study Type:
Observational
Actual Enrollment
:
2029 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
SPECIAL INVESTIGATION OF XALKORI FOR NSCLC (REGULATORY POST MARKETING COMMITMENT PLAN)
Actual Study Start Date
:
May 29, 2012
Actual Primary Completion Date
:
Mar 16, 2018
Actual Study Completion Date
:
Mar 16, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Crizotinib (Xalkori)
|
Drug: Crizotinib (Xalkori)
XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg This surveillance is all cases surveillance based on Japanese regulation. Frequency and duration are according to Package Insert as follows. " The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. "
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Drug Reactions [52 weeks]
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XALKORI Capsules in a participant who received XALKORI Capsules. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XALKORI Capsules was assessed by the physician.
Secondary Outcome Measures
- Objective Response Rate (ORR) at 52 Weeks [52 weeks]
Clinical effectiveness of XALKORI Capsules was assessed as "complete response (CR)", "partial response (PR)", "stable disease (SD)", "progressive disease (PD)", or "indeterminate" by the physician, based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Overall effectiveness of XALKORI Capsules was determined by the physician based on the best response. Clinical effectiveness rate was ORR, defined as the percentage of subjects achieving CR or PR with best response. The ORR was presented along with the corresponding exact 2-sided 95% confidence interval (CI).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- All the patients whom an investigator prescribes XALKORI. (Patients need to be administered Crizotinib (XALKORI) in order to be enrolled in this all cases surveillance.)
Exclusion Criteria:
- Patients not administered XALKORI in spite of enrolled.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01597258
Other Study ID Numbers:
- A8081031
First Posted:
May 14, 2012
Last Update Posted:
Sep 13, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | XALKORI Capsules (Crizotinib) |
|---|---|
| Arm/Group Description | Participants who received XALKORI Capsules as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion. |
| Period Title: Overall Study | |
| STARTED | 2029 |
| COMPLETED | 2028 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | XALKORI Capsules (Crizotinib) |
|---|---|
| Arm/Group Description | Participants who received XALKORI Capsules as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion. |
| Overall Participants | 2028 |
| Age, Customized (Count of Participants) | |
| <65 years |
1221
60.2%
|
| ≥65 years |
803
39.6%
|
| Unknown |
4
0.2%
|
| Sex/Gender, Customized (Number) [Number] | |
| Male |
937
46.2%
|
| Female |
1087
53.6%
|
| Unknown |
4
0.2%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
Outcome Measures
| Title | Number of Participants With Adverse Drug Reactions |
|---|---|
| Description | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XALKORI Capsules in a participant who received XALKORI Capsules. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XALKORI Capsules was assessed by the physician. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set comprised of participants who satisfied the inclusion criteria and had received XALKORI Capsules at least once. |
| Arm/Group Title | XALKORI Capsules (Crizotinib) |
|---|---|
| Arm/Group Description | Participants who received XALKORI Capsules as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion. |
| Measure Participants | 2028 |
| ADR |
1858
91.6%
|
| Serious ADR |
518
25.5%
|
| Title | Objective Response Rate (ORR) at 52 Weeks |
|---|---|
| Description | Clinical effectiveness of XALKORI Capsules was assessed as "complete response (CR)", "partial response (PR)", "stable disease (SD)", "progressive disease (PD)", or "indeterminate" by the physician, based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Overall effectiveness of XALKORI Capsules was determined by the physician based on the best response. Clinical effectiveness rate was ORR, defined as the percentage of subjects achieving CR or PR with best response. The ORR was presented along with the corresponding exact 2-sided 95% confidence interval (CI). |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The efficacy analysis set (EAS) is comprised in the safety analysis set who had at least one measurable lesion and were evaluated for effectiveness. 1633 participants were included in the EAS. |
| Arm/Group Title | XALKORI Capsules (Crizotinib) |
|---|---|
| Arm/Group Description | Participants who received XALKORI Capsules as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion. |
| Measure Participants | 1633 |
| Number (95% Confidence Interval) [Percentage of participants] |
66.5
3.3%
|
Adverse Events
| Time Frame | 52 weeks | |
|---|---|---|
| Adverse Event Reporting Description | The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study. | |
| Arm/Group Title | XALKORI Capsules (Crizotinib) | |
| Arm/Group Description | Participants who received XALKORI Capsules as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion. | |
All Cause Mortality |
||
| XALKORI Capsules (Crizotinib) | ||
| Affected / at Risk (%) | # Events | |
| Total | 436/2028 (21.5%) | |
Serious Adverse Events |
||
| XALKORI Capsules (Crizotinib) | ||
| Affected / at Risk (%) | # Events | |
| Total | 777/2028 (38.3%) | |
| Blood and lymphatic system disorders | ||
| Neutropenia | 12/2028 (0.6%) | |
| Leukopenia | 4/2028 (0.2%) | |
| Febrile neutropenia | 7/2028 (0.3%) | |
| Disseminated intravascular coagulation | 5/2028 (0.2%) | |
| Anaemia | 9/2028 (0.4%) | |
| Cardiac disorders | ||
| Sinus bradycardia | 1/2028 (0%) | |
| Pericardial effusion | 4/2028 (0.2%) | |
| Long QT syndrome | 1/2028 (0%) | |
| Cardio-respiratory arrest | 1/2028 (0%) | |
| Cardiac tamponade | 1/2028 (0%) | |
| Cardiac failure chronic | 1/2028 (0%) | |
| Cardiac failure acute | 1/2028 (0%) | |
| Cardiac failure | 11/2028 (0.5%) | |
| Cardiac arrest | 1/2028 (0%) | |
| Bradycardia | 7/2028 (0.3%) | |
| Arrhythmia | 1/2028 (0%) | |
| Acute myocardial infarction | 1/2028 (0%) | |
| Congenital, familial and genetic disorders | ||
| Tracheo-oesophageal fistula | 1/2028 (0%) | |
| Ear and labyrinth disorders | ||
| Vertigo | 1/2028 (0%) | |
| Endocrine disorders | ||
| Inappropriate antidiuretic hormone secretion | 1/2028 (0%) | |
| Eye disorders | ||
| Visual impairment | 2/2028 (0.1%) | |
| Vision blurred | 2/2028 (0.1%) | |
| Photopsia | 1/2028 (0%) | |
| Photophobia | 1/2028 (0%) | |
| Macular hole | 1/2028 (0%) | |
| Glaucoma | 1/2028 (0%) | |
| Eye disorder | 1/2028 (0%) | |
| Diplopia | 1/2028 (0%) | |
| Cataract | 1/2028 (0%) | |
| Gastrointestinal disorders | ||
| Vomiting | 37/2028 (1.8%) | |
| Upper gastrointestinal haemorrhage | 1/2028 (0%) | |
| Small intestinal perforation | 1/2028 (0%) | |
| Proctitis | 1/2028 (0%) | |
| Pneumatosis intestinalis | 1/2028 (0%) | |
| Pancreatitis acute | 1/2028 (0%) | |
| Oesophagitis | 16/2028 (0.8%) | |
| Oesophageal ulcer | 7/2028 (0.3%) | |
| Oesophageal perforation | 1/2028 (0%) | |
| Oesophageal pain | 1/2028 (0%) | |
| Oesophageal fistula | 1/2028 (0%) | |
| Obstructive pancreatitis | 1/2028 (0%) | |
| Necrotising oesophagitis | 1/2028 (0%) | |
| Nausea | 34/2028 (1.7%) | |
| Large intestine perforation | 2/2028 (0.1%) | |
| Intestinal obstruction | 3/2028 (0.1%) | |
| Ileus | 4/2028 (0.2%) | |
| Haematemesis | 2/2028 (0.1%) | |
| Gastrooesophageal reflux disease | 1/2028 (0%) | |
| Gastrointestinal toxicity | 1/2028 (0%) | |
| Gastrointestinal oedema | 1/2028 (0%) | |
| Gastrointestinal haemorrhage | 1/2028 (0%) | |
| Gastric ulcer | 1/2028 (0%) | |
| Enterocolitis | 1/2028 (0%) | |
| Dysphagia | 1/2028 (0%) | |
| Dyspepsia | 1/2028 (0%) | |
| Duodenal ulcer haemorrhage | 1/2028 (0%) | |
| Diarrhoea | 7/2028 (0.3%) | |
| Constipation | 1/2028 (0%) | |
| Colitis ischaemic | 1/2028 (0%) | |
| Colitis | 1/2028 (0%) | |
| Anorectal disorder | 1/2028 (0%) | |
| Abdominal pain upper | 1/2028 (0%) | |
| Abdominal pain | 4/2028 (0.2%) | |
| Abdominal discomfort | 1/2028 (0%) | |
| General disorders | ||
| Sudden death | 1/2028 (0%) | |
| Pyrexia | 12/2028 (0.6%) | |
| Pain | 1/2028 (0%) | |
| Oedema peripheral | 4/2028 (0.2%) | |
| Oedema | 8/2028 (0.4%) | |
| Multiple organ dysfunction syndrome | 1/2028 (0%) | |
| Malaise | 5/2028 (0.2%) | |
| General physical health deterioration | 1/2028 (0%) | |
| Face oedema | 1/2028 (0%) | |
| Drug interaction | 1/2028 (0%) | |
| Death | 5/2028 (0.2%) | |
| Asthenia | 1/2028 (0%) | |
| Hepatobiliary disorders | ||
| Liver disorder | 15/2028 (0.7%) | |
| Hepatotoxicity | 18/2028 (0.9%) | |
| Hepatitis fulminant | 2/2028 (0.1%) | |
| Hepatitis acute | 2/2028 (0.1%) | |
| Hepatic necrosis | 1/2028 (0%) | |
| Hepatic function abnormal | 52/2028 (2.6%) | |
| Hepatic failure | 2/2028 (0.1%) | |
| Drug-induced liver injury | 5/2028 (0.2%) | |
| Cholecystitis chronic | 1/2028 (0%) | |
| Cholecystitis | 2/2028 (0.1%) | |
| Cholangitis | 1/2028 (0%) | |
| Biliary dilatation | 1/2028 (0%) | |
| Bile duct stone | 1/2028 (0%) | |
| Bile duct obstruction | 1/2028 (0%) | |
| Infections and infestations | ||
| Wound infection | 1/2028 (0%) | |
| Urinary tract infection | 5/2028 (0.2%) | |
| Sepsis | 5/2028 (0.2%) | |
| Renal cyst infection | 2/2028 (0.1%) | |
| Renal abscess | 12/2028 (0.6%) | |
| Pyelonephritis acute | 1/2028 (0%) | |
| Pyelonephritis | 2/2028 (0.1%) | |
| Psoas abscess | 2/2028 (0.1%) | |
| Pseudomembranous colitis | 1/2028 (0%) | |
| Pneumonia pneumococcal | 3/2028 (0.1%) | |
| Pneumonia influenzal | 1/2028 (0%) | |
| Pneumonia herpes viral | 1/2028 (0%) | |
| Pneumonia cytomegaloviral | 1/2028 (0%) | |
| Pneumonia bacterial | 12/2028 (0.6%) | |
| Pneumonia | 45/2028 (2.2%) | |
| Pneumocystis jirovecii pneumonia | 5/2028 (0.2%) | |
| Peritonitis | 2/2028 (0.1%) | |
| Perinephric abscess | 1/2028 (0%) | |
| Otitis media | 1/2028 (0%) | |
| Oesophageal candidiasis | 3/2028 (0.1%) | |
| Muscle abscess | 1/2028 (0%) | |
| Mediastinitis | 1/2028 (0%) | |
| Lung infection | 5/2028 (0.2%) | |
| Lung abscess | 1/2028 (0%) | |
| Localised infection | 1/2028 (0%) | |
| Liver abscess | 2/2028 (0.1%) | |
| Kidney infection | 1/2028 (0%) | |
| Infective exacerbation of bronchiectasis | 1/2028 (0%) | |
| Infectious pleural effusion | 3/2028 (0.1%) | |
| Infection | 1/2028 (0%) | |
| Herpes zoster | 3/2028 (0.1%) | |
| Gastroenteritis salmonella | 1/2028 (0%) | |
| Gastroenteritis | 1/2028 (0%) | |
| Enteritis infectious | 1/2028 (0%) | |
| Cellulitis | 1/2028 (0%) | |
| Bronchopulmonary aspergillosis | 1/2028 (0%) | |
| Bronchitis | 2/2028 (0.1%) | |
| Bacteraemia | 1/2028 (0%) | |
| Atypical pneumonia | 1/2028 (0%) | |
| Arthritis bacterial | 1/2028 (0%) | |
| Appendicitis | 2/2028 (0.1%) | |
| Abdominal abscess | 1/2028 (0%) | |
| Injury, poisoning and procedural complications | ||
| Spinal fracture | 1/2028 (0%) | |
| Spinal compression fracture | 3/2028 (0.1%) | |
| Radiation pneumonitis | 2/2028 (0.1%) | |
| Humerus fracture | 1/2028 (0%) | |
| Fracture | 1/2028 (0%) | |
| Femur fracture | 2/2028 (0.1%) | |
| Compression fracture | 1/2028 (0%) | |
| Investigations | ||
| White blood cell count increased | 1/2028 (0%) | |
| White blood cell count decreased | 5/2028 (0.2%) | |
| Weight increased | 1/2028 (0%) | |
| Renal function test abnormal | 1/2028 (0%) | |
| Platelet count decreased | 5/2028 (0.2%) | |
| Neutrophil count decreased | 22/2028 (1.1%) | |
| Hepatic enzyme increased | 1/2028 (0%) | |
| Haemoglobin decreased | 1/2028 (0%) | |
| Gamma-glutamyltransferase increased | 1/2028 (0%) | |
| Eosinophil count increased | 1/2028 (0%) | |
| Electrocardiogram T wave abnormal | 1/2028 (0%) | |
| Electrocardiogram QT prolonged | 10/2028 (0.5%) | |
| C-reactive protein increased | 3/2028 (0.1%) | |
| Blood creatinine increased | 12/2028 (0.6%) | |
| Blood creatine phosphokinase increased | 1/2028 (0%) | |
| Blood bilirubin increased | 3/2028 (0.1%) | |
| Blood alkaline phosphatase increased | 2/2028 (0.1%) | |
| Blood albumin decreased | 1/2028 (0%) | |
| Aspartate aminotransferase increased | 22/2028 (1.1%) | |
| Alanine aminotransferase increased | 22/2028 (1.1%) | |
| Metabolism and nutrition disorders | ||
| Tumour lysis syndrome | 3/2028 (0.1%) | |
| Metabolic acidosis | 1/2028 (0%) | |
| Hyponatraemia | 5/2028 (0.2%) | |
| Hypokalaemia | 2/2028 (0.1%) | |
| Hypocalcaemia | 5/2028 (0.2%) | |
| Hypoalbuminaemia | 4/2028 (0.2%) | |
| Hyperkalaemia | 6/2028 (0.3%) | |
| Hyperglycaemia | 2/2028 (0.1%) | |
| Hypercalcaemia | 1/2028 (0%) | |
| Fluid overload | 1/2028 (0%) | |
| Dehydration | 4/2028 (0.2%) | |
| Decreased appetite | 19/2028 (0.9%) | |
| Musculoskeletal and connective tissue disorders | ||
| Muscular weakness | 1/2028 (0%) | |
| Muscle atrophy | 1/2028 (0%) | |
| Lumbar spinal stenosis | 1/2028 (0%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Small cell lung cancer | 1/2028 (0%) | |
| Second primary malignancy | 1/2028 (0%) | |
| Plasma cell myeloma | 1/2028 (0%) | |
| Non-small cell lung cancer | 293/2028 (14.4%) | |
| Metastases to lung | 1/2028 (0%) | |
| Metastases to central nervous system | 1/2028 (0%) | |
| Malignant ascites | 1/2028 (0%) | |
| Lung adenocarcinoma | 1/2028 (0%) | |
| Intracranial tumour haemorrhage | 1/2028 (0%) | |
| Gastric cancer | 1/2028 (0%) | |
| Cancer pain | 1/2028 (0%) | |
| Anaplastic large-cell lymphoma | 1/2028 (0%) | |
| Nervous system disorders | ||
| Syncope | 1/2028 (0%) | |
| Somnolence | 1/2028 (0%) | |
| Seizure | 6/2028 (0.3%) | |
| Presyncope | 1/2028 (0%) | |
| Peripheral sensory neuropathy | 1/2028 (0%) | |
| Peripheral motor neuropathy | 2/2028 (0.1%) | |
| Paraneoplastic neurological syndrome | 1/2028 (0%) | |
| Neuropathy peripheral | 3/2028 (0.1%) | |
| Neuralgia | 1/2028 (0%) | |
| Myasthenia gravis | 1/2028 (0%) | |
| Loss of consciousness | 1/2028 (0%) | |
| Leukoencephalopathy | 1/2028 (0%) | |
| Lacunar infarction | 1/2028 (0%) | |
| Hemiplegia | 1/2028 (0%) | |
| Guillain-Barre syndrome | 1/2028 (0%) | |
| Facial paralysis | 1/2028 (0%) | |
| Epilepsy | 2/2028 (0.1%) | |
| Encephalopathy | 1/2028 (0%) | |
| Dysgeusia | 3/2028 (0.1%) | |
| Dysarthria | 1/2028 (0%) | |
| Drug withdrawal convulsions | 1/2028 (0%) | |
| Dizziness | 3/2028 (0.1%) | |
| Depressed level of consciousness | 7/2028 (0.3%) | |
| Cerebellar infarction | 1/2028 (0%) | |
| Brain oedema | 4/2028 (0.2%) | |
| Altered state of consciousness | 2/2028 (0.1%) | |
| Akathisia | 1/2028 (0%) | |
| Psychiatric disorders | ||
| Suicide attempt | 3/2028 (0.1%) | |
| Major depression | 1/2028 (0%) | |
| Disorientation | 1/2028 (0%) | |
| Delirium | 5/2028 (0.2%) | |
| Completed suicide | 1/2028 (0%) | |
| Renal and urinary disorders | ||
| Urinary tract obstruction | 1/2028 (0%) | |
| Urinary retention | 1/2028 (0%) | |
| Tubulointerstitial nephritis | 1/2028 (0%) | |
| Renal impairment | 7/2028 (0.3%) | |
| Renal disorder | 3/2028 (0.1%) | |
| Renal cyst | 4/2028 (0.2%) | |
| Neurogenic bladder | 1/2028 (0%) | |
| Bladder disorder | 1/2028 (0%) | |
| Acute kidney injury | 4/2028 (0.2%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Respiratory failure | 12/2028 (0.6%) | |
| Pulmonary oedema | 3/2028 (0.1%) | |
| Pulmonary infarction | 1/2028 (0%) | |
| Pulmonary fibrosis | 2/2028 (0.1%) | |
| Pulmonary embolism | 22/2028 (1.1%) | |
| Pulmonary artery thrombosis | 1/2028 (0%) | |
| Pulmonary alveolar haemorrhage | 2/2028 (0.1%) | |
| Pneumothorax | 1/2028 (0%) | |
| Pneumonitis | 4/2028 (0.2%) | |
| Pneumonia aspiration | 11/2028 (0.5%) | |
| Pleurisy | 3/2028 (0.1%) | |
| Acute respiratory distress syndrome | 4/2028 (0.2%) | |
| Acute respiratory failure | 1/2028 (0%) | |
| Apnoea | 1/2028 (0%) | |
| Asphyxia | 1/2028 (0%) | |
| Aspiration | 3/2028 (0.1%) | |
| Asthma | 1/2028 (0%) | |
| Chylothorax | 1/2028 (0%) | |
| Cough | 1/2028 (0%) | |
| Dyspnoea | 8/2028 (0.4%) | |
| Dyspnoea exertional | 1/2028 (0%) | |
| Haemoptysis | 3/2028 (0.1%) | |
| Hypoxia | 5/2028 (0.2%) | |
| Interstitial lung disease | 84/2028 (4.1%) | |
| Laryngeal oedema | 1/2028 (0%) | |
| Lung disorder | 5/2028 (0.2%) | |
| Obstructive airways disorder | 1/2028 (0%) | |
| Organising pneumonia | 3/2028 (0.1%) | |
| Pleural effusion | 12/2028 (0.6%) | |
| Skin and subcutaneous tissue disorders | ||
| Toxic skin eruption | 1/2028 (0%) | |
| Rash maculo-papular | 1/2028 (0%) | |
| Rash | 1/2028 (0%) | |
| Erythema multiforme | 4/2028 (0.2%) | |
| Erythema | 1/2028 (0%) | |
| Drug eruption | 1/2028 (0%) | |
| Dermatitis | 1/2028 (0%) | |
| Vascular disorders | ||
| Venous thrombosis limb | 2/2028 (0.1%) | |
| Vena cava thrombosis | 1/2028 (0%) | |
| Thrombosis | 1/2028 (0%) | |
| Thrombophlebitis superficial | 1/2028 (0%) | |
| Peripheral circulatory failure | 1/2028 (0%) | |
| Hypotension | 4/2028 (0.2%) | |
| Embolism venous | 1/2028 (0%) | |
| Embolism | 1/2028 (0%) | |
| Deep vein thrombosis | 10/2028 (0.5%) | |
| Circulatory collapse | 1/2028 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| XALKORI Capsules (Crizotinib) | ||
| Affected / at Risk (%) | # Events | |
| Total | 1783/2028 (87.9%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 78/2028 (3.8%) | |
| Coagulopathy | 1/2028 (0%) | |
| Disseminated intravascular coagulation | 3/2028 (0.1%) | |
| Febrile neutropenia | 6/2028 (0.3%) | |
| Leukocytosis | 3/2028 (0.1%) | |
| Leukopenia | 14/2028 (0.7%) | |
| Lymphadenitis | 1/2028 (0%) | |
| Lymphopenia | 2/2028 (0.1%) | |
| Neutropenia | 45/2028 (2.2%) | |
| Pancytopenia | 1/2028 (0%) | |
| Thrombocytopenia | 4/2028 (0.2%) | |
| Cardiac disorders | ||
| Angina pectoris | 1/2028 (0%) | |
| Atrial fibrillation | 2/2028 (0.1%) | |
| Bradycardia | 90/2028 (4.4%) | |
| Cardiac failure | 3/2028 (0.1%) | |
| Cardiac tamponade | 1/2028 (0%) | |
| Cardiac ventricular thrombosis | 1/2028 (0%) | |
| Conduction disorder | 1/2028 (0%) | |
| Palpitations | 5/2028 (0.2%) | |
| Pericardial effusion | 3/2028 (0.1%) | |
| Pericarditis | 1/2028 (0%) | |
| Sinus bradycardia | 34/2028 (1.7%) | |
| Tachycardia | 2/2028 (0.1%) | |
| Ventricular arrhythmia | 1/2028 (0%) | |
| Congenital, familial and genetic disorders | ||
| Colour blindness | 1/2028 (0%) | |
| Congenital cystic kidney disease | 1/2028 (0%) | |
| Ear and labyrinth disorders | ||
| Deafness | 2/2028 (0.1%) | |
| Ear discomfort | 2/2028 (0.1%) | |
| Tinnitus | 4/2028 (0.2%) | |
| Vertigo | 1/2028 (0%) | |
| Endocrine disorders | ||
| Hypothyroidism | 3/2028 (0.1%) | |
| Eye disorders | ||
| Visual impairment | 195/2028 (9.6%) | |
| Photopsia | 384/2028 (18.9%) | |
| Abnormal sensation in eye | 1/2028 (0%) | |
| Accommodation disorder | 1/2028 (0%) | |
| Asthenopia | 1/2028 (0%) | |
| Blepharitis | 1/2028 (0%) | |
| Cataract | 2/2028 (0.1%) | |
| Cataract subcapsular | 1/2028 (0%) | |
| Conjunctival haemorrhage | 1/2028 (0%) | |
| Diabetic retinopathy | 1/2028 (0%) | |
| Diplopia | 87/2028 (4.3%) | |
| Dry eye | 4/2028 (0.2%) | |
| Extraocular muscle paresis | 1/2028 (0%) | |
| Eye disorder | 6/2028 (0.3%) | |
| Eyelid oedema | 2/2028 (0.1%) | |
| Hypermetropia | 1/2028 (0%) | |
| Keratitis | 1/2028 (0%) | |
| Lacrimation increased | 1/2028 (0%) | |
| Night blindness | 2/2028 (0.1%) | |
| Optic nerve disorder | 2/2028 (0.1%) | |
| Periorbital oedema | 2/2028 (0.1%) | |
| Photophobia | 54/2028 (2.7%) | |
| Punctate keratitis | 1/2028 (0%) | |
| Retinal tear | 1/2028 (0%) | |
| Vision blurred | 85/2028 (4.2%) | |
| Visual acuity reduced | 4/2028 (0.2%) | |
| Vitreous floaters | 28/2028 (1.4%) | |
| Gastrointestinal disorders | ||
| Vomiting | 326/2028 (16.1%) | |
| Nausea | 633/2028 (31.2%) | |
| Diarrhoea | 500/2028 (24.7%) | |
| Constipation | 299/2028 (14.7%) | |
| Abdominal discomfort | 19/2028 (0.9%) | |
| Abdominal distension | 10/2028 (0.5%) | |
| Abdominal pain | 24/2028 (1.2%) | |
| Abdominal pain lower | 1/2028 (0%) | |
| Abdominal pain upper | 29/2028 (1.4%) | |
| Anal inflammation | 1/2028 (0%) | |
| Ascites | 5/2028 (0.2%) | |
| Cheilitis | 5/2028 (0.2%) | |
| Chronic gastritis | 2/2028 (0.1%) | |
| Crohn's disease | 1/2028 (0%) | |
| Dental caries | 1/2028 (0%) | |
| Dumping syndrome | 1/2028 (0%) | |
| Dyspepsia | 12/2028 (0.6%) | |
| Dysphagia | 11/2028 (0.5%) | |
| Enterocolitis | 6/2028 (0.3%) | |
| Epigastric discomfort | 3/2028 (0.1%) | |
| Faeces soft | 10/2028 (0.5%) | |
| Food poisoning | 2/2028 (0.1%) | |
| Gastric ulcer | 2/2028 (0.1%) | |
| Gastritis | 19/2028 (0.9%) | |
| Gastritis haemorrhagic | 1/2028 (0%) | |
| Gastrointestinal disorder | 6/2028 (0.3%) | |
| Gastrointestinal mucosal disorder | 1/2028 (0%) | |
| Gastrointestinal oedema | 1/2028 (0%) | |
| Gastrointestinal pain | 4/2028 (0.2%) | |
| Gastrooesophageal reflux disease | 23/2028 (1.1%) | |
| Glossodynia | 1/2028 (0%) | |
| Haematochezia | 1/2028 (0%) | |
| Haemorrhoidal haemorrhage | 1/2028 (0%) | |
| Haemorrhoids | 4/2028 (0.2%) | |
| Hiatus hernia | 1/2028 (0%) | |
| Hypoaesthesia oral | 2/2028 (0.1%) | |
| Ileus | 2/2028 (0.1%) | |
| Intestinal dilatation | 1/2028 (0%) | |
| Irritable bowel syndrome | 1/2028 (0%) | |
| Lip erosion | 1/2028 (0%) | |
| Lip swelling | 1/2028 (0%) | |
| Melaena | 1/2028 (0%) | |
| Mouth haemorrhage | 1/2028 (0%) | |
| Odynophagia | 5/2028 (0.2%) | |
| Oesophageal pain | 6/2028 (0.3%) | |
| Oesophageal stenosis | 1/2028 (0%) | |
| Oesophageal ulcer | 9/2028 (0.4%) | |
| Oesophagitis | 40/2028 (2%) | |
| Oral dysaesthesia | 2/2028 (0.1%) | |
| Oral pain | 1/2028 (0%) | |
| Pancreatic cyst | 1/2028 (0%) | |
| Pancreatitis acute | 1/2028 (0%) | |
| Periodontal disease | 1/2028 (0%) | |
| Stomatitis | 34/2028 (1.7%) | |
| Subileus | 2/2028 (0.1%) | |
| General disorders | ||
| Pyrexia | 118/2028 (5.8%) | |
| Oedema peripheral | 118/2028 (5.8%) | |
| Asthenia | 1/2028 (0%) | |
| Chest discomfort | 1/2028 (0%) | |
| Chest pain | 7/2028 (0.3%) | |
| Chills | 1/2028 (0%) | |
| Face oedema | 11/2028 (0.5%) | |
| Fatigue | 18/2028 (0.9%) | |
| Feeling abnormal | 1/2028 (0%) | |
| Generalised oedema | 3/2028 (0.1%) | |
| Infusion site extravasation | 2/2028 (0.1%) | |
| Localised oedema | 3/2028 (0.1%) | |
| Malaise | 93/2028 (4.6%) | |
| Non-cardiac chest pain | 1/2028 (0%) | |
| Oedema | 82/2028 (4%) | |
| Pain | 11/2028 (0.5%) | |
| Sensation of foreign body | 1/2028 (0%) | |
| Thirst | 1/2028 (0%) | |
| Hepatobiliary disorders | ||
| Liver disorder | 145/2028 (7.1%) | |
| Hepatic function abnormal | 249/2028 (12.3%) | |
| Cholangitis | 1/2028 (0%) | |
| Drug-induced liver injury | 6/2028 (0.3%) | |
| Hepatic cyst | 1/2028 (0%) | |
| Hepatic failure | 1/2028 (0%) | |
| Hepatic steatosis | 3/2028 (0.1%) | |
| Hepatitis | 1/2028 (0%) | |
| Hepatotoxicity | 69/2028 (3.4%) | |
| Hepatobiliary disease | 3/2028 (0.1%) | |
| Immune system disorders | ||
| Hypogammaglobulinaemia | 1/2028 (0%) | |
| Seasonal allergy | 4/2028 (0.2%) | |
| Infections and infestations | ||
| Abscess oral | 1/2028 (0%) | |
| Angular cheilitis | 2/2028 (0.1%) | |
| Appendicitis | 1/2028 (0%) | |
| Atypical mycobacterial infection | 1/2028 (0%) | |
| Bacterial infection | 1/2028 (0%) | |
| Bronchitis | 23/2028 (1.1%) | |
| Cellulitis | 5/2028 (0.2%) | |
| Conjunctivitis | 4/2028 (0.2%) | |
| Cystitis | 12/2028 (0.6%) | |
| Device related infection | 1/2028 (0%) | |
| Enteritis infectious | 2/2028 (0.1%) | |
| Enterocolitis bacterial | 1/2028 (0%) | |
| Folliculitis | 1/2028 (0%) | |
| Gastroenteritis | 4/2028 (0.2%) | |
| Gingivitis | 3/2028 (0.1%) | |
| Herpes simplex | 1/2028 (0%) | |
| Herpes zoster | 13/2028 (0.6%) | |
| Infection | 6/2028 (0.3%) | |
| Infectious pleural effusion | 2/2028 (0.1%) | |
| Influenza | 3/2028 (0.1%) | |
| Lower respiratory tract infection | 1/2028 (0%) | |
| Lung abscess | 2/2028 (0.1%) | |
| Lung infection | 13/2028 (0.6%) | |
| Nasopharyngitis | 23/2028 (1.1%) | |
| Oesophageal candidiasis | 9/2028 (0.4%) | |
| Oral candidiasis | 6/2028 (0.3%) | |
| Oral herpes | 4/2028 (0.2%) | |
| Oropharyngeal candidiasis | 1/2028 (0%) | |
| Osteomyelitis | 1/2028 (0%) | |
| Otitis externa | 1/2028 (0%) | |
| Otitis media | 2/2028 (0.1%) | |
| Otitis media acute | 1/2028 (0%) | |
| Paronychia | 2/2028 (0.1%) | |
| Parotitis | 1/2028 (0%) | |
| Peritonitis | 1/2028 (0%) | |
| Pharyngitis | 9/2028 (0.4%) | |
| Pneumocystis jirovecii pneumonia | 1/2028 (0%) | |
| Pneumonia | 51/2028 (2.5%) | |
| Pneumonia bacterial | 6/2028 (0.3%) | |
| Pulmonary tuberculosis | 1/2028 (0%) | |
| Pyelonephritis | 1/2028 (0%) | |
| Rhinitis | 1/2028 (0%) | |
| Sinusitis | 2/2028 (0.1%) | |
| Skin candida | 1/2028 (0%) | |
| Skin infection | 2/2028 (0.1%) | |
| Tinea infection | 1/2028 (0%) | |
| Tinea pedis | 4/2028 (0.2%) | |
| Tonsillitis | 1/2028 (0%) | |
| Tooth infection | 1/2028 (0%) | |
| Tuberculosis | 1/2028 (0%) | |
| Upper respiratory tract infection | 10/2028 (0.5%) | |
| Urinary tract infection | 20/2028 (1%) | |
| Respiratory tract infection | 1/2028 (0%) | |
| Injury, poisoning and procedural complications | ||
| Chest injury | 1/2028 (0%) | |
| Chillblains | 1/2028 (0%) | |
| Closed globe injury | 1/2028 (0%) | |
| Compression fracture | 1/2028 (0%) | |
| Fall | 1/2028 (0%) | |
| Femur fracture | 1/2028 (0%) | |
| Fracture | 2/2028 (0.1%) | |
| Pelvic fracture | 1/2028 (0%) | |
| Post procedural haemorrhage | 1/2028 (0%) | |
| Radiation oesophagitis | 2/2028 (0.1%) | |
| Radiation pneumonitis | 11/2028 (0.5%) | |
| Rib fracture | 2/2028 (0.1%) | |
| Recall phenomenon | 2/2028 (0.1%) | |
| Spinal compression fracture | 5/2028 (0.2%) | |
| Tendon rupture | 1/2028 (0%) | |
| Tracheal haemorrhage | 1/2028 (0%) | |
| Wound complication | 1/2028 (0%) | |
| Fibula fracture | 1/2028 (0%) | |
| Investigations | ||
| White blood cell count decreased | 109/2028 (5.4%) | |
| Blood creatinine increased | 190/2028 (9.4%) | |
| Neutrophil count decreased | 166/2028 (8.2%) | |
| Blood alkaline phosphatase increased | 115/2028 (5.7%) | |
| Aspartate aminotransferase increased | 271/2028 (13.4%) | |
| Alanine aminotransferase increased | 291/2028 (14.3%) | |
| Amylase increased | 2/2028 (0.1%) | |
| Beta 2 microglobulin increased | 1/2028 (0%) | |
| Blood bilirubin increased | 9/2028 (0.4%) | |
| Blood calcium decreased | 1/2028 (0%) | |
| Blood chloride decreased | 2/2028 (0.1%) | |
| Blood chloride increased | 3/2028 (0.1%) | |
| Blood creatine phosphokinase increased | 29/2028 (1.4%) | |
| Blood lactate dehydrogenase increased | 23/2028 (1.1%) | |
| Blood potassium increased | 5/2028 (0.2%) | |
| Blood pressure decreased | 1/2028 (0%) | |
| Blood urea abnormal | 1/2028 (0%) | |
| Blood urea increased | 24/2028 (1.2%) | |
| Carbohydrate antigen 19-9 increased | 1/2028 (0%) | |
| Carcinoembryonic antigen increased | 3/2028 (0.1%) | |
| Cardioactive drug level increased | 1/2028 (0%) | |
| Cell marker increased | 2/2028 (0.1%) | |
| Chest X-ray abnormal | 1/2028 (0%) | |
| C-reactive protein increased | 11/2028 (0.5%) | |
| Creatinine renal clearance decreased | 1/2028 (0%) | |
| Electrocardiogram QT prolonged | 65/2028 (3.2%) | |
| Gamma-glutamyltransferase increased | 9/2028 (0.4%) | |
| Granulocyte count decreased | 1/2028 (0%) | |
| Grip strength decreased | 1/2028 (0%) | |
| Haemoglobin decreased | 9/2028 (0.4%) | |
| Hepatic enzyme increased | 9/2028 (0.4%) | |
| International normalised ratio increased | 3/2028 (0.1%) | |
| Intraocular pressure increased | 2/2028 (0.1%) | |
| Investigation abnormal | 1/2028 (0%) | |
| Liver function test abnormal | 7/2028 (0.3%) | |
| Liver function test increased | 9/2028 (0.4%) | |
| Lymphocyte count decreased | 22/2028 (1.1%) | |
| Lymphocyte count increased | 1/2028 (0%) | |
| Monocyte count increased | 1/2028 (0%) | |
| Neutrophil count increased | 1/2028 (0%) | |
| Nutritional condition abnormal | 1/2028 (0%) | |
| Oxygen saturation decreased | 1/2028 (0%) | |
| Platelet count decreased | 16/2028 (0.8%) | |
| Platelet count increased | 4/2028 (0.2%) | |
| Protein total decreased | 5/2028 (0.2%) | |
| Prothrombin time prolonged | 1/2028 (0%) | |
| Red blood cell count decreased | 1/2028 (0%) | |
| Renal function test abnormal | 1/2028 (0%) | |
| Transaminases increased | 10/2028 (0.5%) | |
| Tumour marker increased | 2/2028 (0.1%) | |
| Vitamin B12 decreased | 1/2028 (0%) | |
| Weight decreased | 5/2028 (0.2%) | |
| Weight increased | 2/2028 (0.1%) | |
| White blood cell count increased | 14/2028 (0.7%) | |
| Blood albumin decreased | 5/2028 (0.2%) | |
| Eosinophil count increased | 7/2028 (0.3%) | |
| Glomerular filtration rate decreased | 2/2028 (0.1%) | |
| Red blood cell count increased | 1/2028 (0%) | |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 210/2028 (10.4%) | |
| Dehydration | 8/2028 (0.4%) | |
| Diabetes mellitus | 3/2028 (0.1%) | |
| Fluid retention | 1/2028 (0%) | |
| Hyperchloraemia | 1/2028 (0%) | |
| Hyperglycaemia | 4/2028 (0.2%) | |
| Hyperkalaemia | 43/2028 (2.1%) | |
| Hypermagnesaemia | 1/2028 (0%) | |
| Hyperphosphatasaemia | 5/2028 (0.2%) | |
| Hypertriglyceridaemia | 1/2028 (0%) | |
| Hyperuricaemia | 6/2028 (0.3%) | |
| Hypoalbuminaemia | 25/2028 (1.2%) | |
| Hypocalcaemia | 22/2028 (1.1%) | |
| Hypoglycaemia | 2/2028 (0.1%) | |
| Hypokalaemia | 11/2028 (0.5%) | |
| Hyponatraemia | 15/2028 (0.7%) | |
| Hypophosphataemia | 1/2028 (0%) | |
| Hypoproteinaemia | 3/2028 (0.1%) | |
| Hypozincaemia | 1/2028 (0%) | |
| Tumour lysis syndrome | 1/2028 (0%) | |
| Zinc deficiency | 1/2028 (0%) | |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 8/2028 (0.4%) | |
| Arthritis | 1/2028 (0%) | |
| Back pain | 16/2028 (0.8%) | |
| Bone pain | 1/2028 (0%) | |
| Intervertebral disc protrusion | 1/2028 (0%) | |
| Muscle spasms | 3/2028 (0.1%) | |
| Muscle twitching | 1/2028 (0%) | |
| Muscular weakness | 2/2028 (0.1%) | |
| Musculoskeletal pain | 6/2028 (0.3%) | |
| Musculoskeletal stiffness | 3/2028 (0.1%) | |
| Myalgia | 6/2028 (0.3%) | |
| Myopathy | 1/2028 (0%) | |
| Neck pain | 2/2028 (0.1%) | |
| Osteitis | 1/2028 (0%) | |
| Osteoarthritis | 1/2028 (0%) | |
| Osteonecrosis | 1/2028 (0%) | |
| Osteoporosis | 1/2028 (0%) | |
| Pain in extremity | 4/2028 (0.2%) | |
| Pain in jaw | 1/2028 (0%) | |
| Periarthritis | 1/2028 (0%) | |
| Rhabdomyolysis | 1/2028 (0%) | |
| Spinal osteoarthritis | 1/2028 (0%) | |
| Musculoskeletal chest pain | 1/2028 (0%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Cancer pain | 5/2028 (0.2%) | |
| Fibrous histiocytoma | 1/2028 (0%) | |
| Gastric cancer | 1/2028 (0%) | |
| Intestinal metastasis | 1/2028 (0%) | |
| Intracranial tumour haemorrhage | 1/2028 (0%) | |
| Lymphangiosis carcinomatosa | 1/2028 (0%) | |
| Metastases to adrenals | 1/2028 (0%) | |
| Metastases to bone | 1/2028 (0%) | |
| Metastases to liver | 1/2028 (0%) | |
| Neoplasm progression | 1/2028 (0%) | |
| Non-small cell lung cancer | 13/2028 (0.6%) | |
| Rectal cancer | 1/2028 (0%) | |
| Tumour associated fever | 1/2028 (0%) | |
| Nervous system disorders | ||
| Dysgeusia | 339/2028 (16.7%) | |
| Altered state of consciousness | 2/2028 (0.1%) | |
| Amnesia | 1/2028 (0%) | |
| Ataxia | 1/2028 (0%) | |
| Brain oedema | 2/2028 (0.1%) | |
| Cerebral infarction | 2/2028 (0.1%) | |
| Cerebral ischaemia | 1/2028 (0%) | |
| Disturbance in attention | 1/2028 (0%) | |
| Dizziness | 55/2028 (2.7%) | |
| Dizziness postural | 6/2028 (0.3%) | |
| Dyslalia | 1/2028 (0%) | |
| Facial neuralgia | 1/2028 (0%) | |
| Headache | 23/2028 (1.1%) | |
| Hypoaesthesia | 21/2028 (1%) | |
| Intracranial pressure increased | 1/2028 (0%) | |
| Loss of consciousness | 2/2028 (0.1%) | |
| Muscle spasticity | 1/2028 (0%) | |
| Nervous system disorder | 1/2028 (0%) | |
| Neuralgia | 7/2028 (0.3%) | |
| Neuropathy peripheral | 28/2028 (1.4%) | |
| Neurotoxicity | 1/2028 (0%) | |
| Paraesthesia | 1/2028 (0%) | |
| Parkinson's disease | 1/2028 (0%) | |
| Peripheral motor neuropathy | 1/2028 (0%) | |
| Peripheral sensory neuropathy | 19/2028 (0.9%) | |
| Pyramidal tract syndrome | 1/2028 (0%) | |
| Sciatica | 1/2028 (0%) | |
| Seizure | 3/2028 (0.1%) | |
| Sensory disturbance | 3/2028 (0.1%) | |
| Somnolence | 8/2028 (0.4%) | |
| Syncope | 2/2028 (0.1%) | |
| Tension headache | 1/2028 (0%) | |
| Transient ischaemic attack | 1/2028 (0%) | |
| Tremor | 1/2028 (0%) | |
| Trigeminal nerve disorder | 1/2028 (0%) | |
| Visual field defect | 8/2028 (0.4%) | |
| Visual perseveration | 77/2028 (3.8%) | |
| Parosmia | 1/2028 (0%) | |
| Psychiatric disorders | ||
| Affective disorder | 1/2028 (0%) | |
| Anticipatory anxiety | 1/2028 (0%) | |
| Anxiety | 4/2028 (0.2%) | |
| Anxiety disorder | 3/2028 (0.1%) | |
| Confusional state | 1/2028 (0%) | |
| Delirium | 11/2028 (0.5%) | |
| Depression | 7/2028 (0.3%) | |
| Dissociative disorder | 1/2028 (0%) | |
| Dysphoria | 1/2028 (0%) | |
| Hallucination | 1/2028 (0%) | |
| Insomnia | 35/2028 (1.7%) | |
| Mental disorder | 1/2028 (0%) | |
| Mood altered | 1/2028 (0%) | |
| Neurosis | 1/2028 (0%) | |
| Restlessness | 2/2028 (0.1%) | |
| Sleep disorder | 1/2028 (0%) | |
| Renal and urinary disorders | ||
| Acute kidney injury | 4/2028 (0.2%) | |
| Chromaturia | 1/2028 (0%) | |
| Chronic kidney disease | 1/2028 (0%) | |
| Dysuria | 3/2028 (0.1%) | |
| Glomerulonephritis chronic | 1/2028 (0%) | |
| Mesangioproliferative glomerulonephritis | 1/2028 (0%) | |
| Nephropathy toxic | 3/2028 (0.1%) | |
| Neurogenic bladder | 2/2028 (0.1%) | |
| Pollakiuria | 1/2028 (0%) | |
| Prerenal failure | 1/2028 (0%) | |
| Proteinuria | 3/2028 (0.1%) | |
| Renal cyst | 12/2028 (0.6%) | |
| Renal disorder | 22/2028 (1.1%) | |
| Renal failure | 1/2028 (0%) | |
| Renal impairment | 73/2028 (3.6%) | |
| Renal vein thrombosis | 1/2028 (0%) | |
| Urethral stenosis | 1/2028 (0%) | |
| Urinary incontinence | 1/2028 (0%) | |
| Urinary retention | 5/2028 (0.2%) | |
| Reproductive system and breast disorders | ||
| Amenorrhoea | 1/2028 (0%) | |
| Benign prostatic hyperplasia | 1/2028 (0%) | |
| Menstruation irregular | 1/2028 (0%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Aspiration | 2/2028 (0.1%) | |
| Asthma | 3/2028 (0.1%) | |
| Cough | 26/2028 (1.3%) | |
| Dysaesthesia pharynx | 1/2028 (0%) | |
| Dysphonia | 2/2028 (0.1%) | |
| Dyspnoea | 13/2028 (0.6%) | |
| Epistaxis | 3/2028 (0.1%) | |
| Haemoptysis | 16/2028 (0.8%) | |
| Hiccups | 5/2028 (0.2%) | |
| Hyperventilation | 1/2028 (0%) | |
| Hypoxia | 4/2028 (0.2%) | |
| Interstitial lung disease | 25/2028 (1.2%) | |
| Laryngeal discomfort | 2/2028 (0.1%) | |
| Laryngeal pain | 1/2028 (0%) | |
| Lung disorder | 2/2028 (0.1%) | |
| Nasal congestion | 1/2028 (0%) | |
| Obliterative bronchiolitis | 1/2028 (0%) | |
| Oropharyngeal discomfort | 3/2028 (0.1%) | |
| Oropharyngeal pain | 14/2028 (0.7%) | |
| Pharyngeal inflammation | 1/2028 (0%) | |
| Pharyngeal stenosis | 1/2028 (0%) | |
| Pleural effusion | 24/2028 (1.2%) | |
| Pleurisy | 2/2028 (0.1%) | |
| Pleuritic pain | 1/2028 (0%) | |
| Pneumomediastinum | 1/2028 (0%) | |
| Pneumonia aspiration | 4/2028 (0.2%) | |
| Pneumonitis | 6/2028 (0.3%) | |
| Pneumothorax | 2/2028 (0.1%) | |
| Productive cough | 3/2028 (0.1%) | |
| Pulmonary artery thrombosis | 1/2028 (0%) | |
| Pulmonary embolism | 2/2028 (0.1%) | |
| Pulmonary fibrosis | 1/2028 (0%) | |
| Pulmonary oedema | 1/2028 (0%) | |
| Respiratory failure | 1/2028 (0%) | |
| Rhinitis allergic | 5/2028 (0.2%) | |
| Rhinorrhoea | 1/2028 (0%) | |
| Upper respiratory tract inflammation | 24/2028 (1.2%) | |
| Wheezing | 2/2028 (0.1%) | |
| Throat irritation | 1/2028 (0%) | |
| Skin and subcutaneous tissue disorders | ||
| Acne | 2/2028 (0.1%) | |
| Alopecia | 7/2028 (0.3%) | |
| Angioedema | 1/2028 (0%) | |
| Asteatosis | 1/2028 (0%) | |
| Decubitus ulcer | 1/2028 (0%) | |
| Dermatitis | 3/2028 (0.1%) | |
| Dermatitis acneiform | 11/2028 (0.5%) | |
| Dermatitis exfoliative | 1/2028 (0%) | |
| Dermatomyositis | 1/2028 (0%) | |
| Drug eruption | 5/2028 (0.2%) | |
| Dry skin | 12/2028 (0.6%) | |
| Eczema | 11/2028 (0.5%) | |
| Eczema asteatotic | 2/2028 (0.1%) | |
| Erythema | 6/2028 (0.3%) | |
| Erythema annulare | 1/2028 (0%) | |
| Erythema multiforme | 4/2028 (0.2%) | |
| Livedo reticularis | 1/2028 (0%) | |
| Mechanical urticaria | 1/2028 (0%) | |
| Papule | 1/2028 (0%) | |
| Photosensitivity reaction | 18/2028 (0.9%) | |
| Pigmentation disorder | 1/2028 (0%) | |
| Pruritus | 19/2028 (0.9%) | |
| Pruritus generalised | 1/2028 (0%) | |
| Psoriasis | 1/2028 (0%) | |
| Rash | 59/2028 (2.9%) | |
| Rash maculo-papular | 5/2028 (0.2%) | |
| Seborrhoeic dermatitis | 2/2028 (0.1%) | |
| Skin disorder | 3/2028 (0.1%) | |
| Skin erosion | 1/2028 (0%) | |
| Skin exfoliation | 1/2028 (0%) | |
| Skin fissures | 1/2028 (0%) | |
| Eczema nummular | 1/2028 (0%) | |
| Toxic skin eruption | 1/2028 (0%) | |
| Urticaria | 7/2028 (0.3%) | |
| Vascular disorders | ||
| Deep vein thrombosis | 7/2028 (0.3%) | |
| Embolism | 3/2028 (0.1%) | |
| Hypertension | 11/2028 (0.5%) | |
| Hypotension | 12/2028 (0.6%) | |
| Lymphoedema | 1/2028 (0%) | |
| Orthostatic hypotension | 2/2028 (0.1%) | |
| Superior vena cava syndrome | 1/2028 (0%) | |
| Venous thrombosis | 1/2028 (0%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01597258
Other Study ID Numbers:
- A8081031
First Posted:
May 14, 2012
Last Update Posted:
Sep 13, 2019
Last Verified:
Sep 1, 2019