Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2005-003670-26 |
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This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1, Group X | Experimental |
| |
| Arm 1, Group Y | Experimental |
| |
| Arm 2, Group X | Experimental |
| |
| Arm 2, Group Y | Experimental | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBH589 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants DLT in Arm 1 in Dose Escalation Phase | Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD. | Cycle 1 (28-day treatment cycle) |
| Number of Participants DLT in Arm 2 in Dose Escalation Phase | Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD. | Cycle 1 (28-day treamtent cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease. | 3.5 years |
| Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia | Augusta | Georgia | 30912 | United States | ||
Not provided
| Label | URL |
|---|---|
| Results for CLBH589B2102 can be found on the Novartis Clinical Trial Results Website | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1, Group X | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. |
| FG001 | Arm 1, Group Y | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. |
| FG002 | Arm 2, Group X | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. |
| FG003 | Arm 2, Group Y | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1, Group X | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants DLT in Arm 1 in Dose Escalation Phase | Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD. | MTD-determining set: Patients in the safety set who were in the dose escalation phase, and who received panobinostat for ≥ 9 full doses in arm 1 in cycle 1 and completed all needed safety evaluations; or who received panobinostat for ≥ 5 full doses in arm 2 in cycle 1 and completed all required safety evaluations; or who experienced DLT in cycle 1. | Posted | Number | Participants | Cycle 1 (28-day treatment cycle) |
|
AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm1, Group X (20 mg) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D007938 | Leukemia |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077767 | Panobinostat |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Stage 2 did not open for enrollment. |
| 1.2 years |
| Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) | Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure. | 3.5 years |
| Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) | Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission. | 3.5 years |
| Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2 | Day 1 |
| Half Life of Panobinostat After the First Dose in Arms 1 and 2 | Day 1 |
| Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15 | From day 15 by dose with schedule: MWF every week | Day 15 |
| Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15 | Day 15 |
| Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 | MWF Every week schedule n = number of subjects with non-missing values. | Day 15/day 1 |
| Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Reporting the number of patients with a reading at the timepoint in the dose group. | Days 1, 5, 8, 10, 15 |
| Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | Days 5, 8, end of study (up to 3.5 years) |
| Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years) |
| Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Days 5, 8, 10, 12, 15, End of study (up to 3.5 years) |
| Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) | All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours])) | Post dose to pre-dose (up to 3.5 years) |
| Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week) | All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours])) | Post dose to pre-dose (up to 3.5 years) |
| Dana Farber Cancer Institute |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| MD Anderson Cancer Center/University of Texas | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Parkville | Victoria | 3002 | Australia |
| Novartis Investigative Site | Prahran | Victoria | 3181 | Australia |
| Novartis Investigative Site | Frankfurt/M | 60590 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Disease progression |
|
| Death |
|
| Adverse Event |
|
| Administrative problems |
|
| Arm 1, Group Y |
panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. |
| BG002 | Arm 2, Group X | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. |
| BG003 | Arm 2, Group Y | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Arm 1, Group X (30 mg) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. |
| OG002 | Arm 1, Group X (40 mg) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. |
| OG003 | Arm 1, Group X (60 mg) - MTD | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication. |
| OG004 | Arm 1, Group X (80 mg) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. |
| OG005 | Arm 1, Group Y (20 mg) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. |
| OG006 | Arm 1, Group Y (30 mg) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. |
| OG007 | Arm 1, Group Y (40 mg) - MTD | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. |
| OG008 | Arm 1, Group Y (60 mg) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. |
|
|
| Primary | Number of Participants DLT in Arm 2 in Dose Escalation Phase | Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD. | MTD-determining population: All patients from the safety population who were in the dose escalation phase of the study, and who received panobinostat for ≥ 9 full doses in arm 1 during cycle 1 and completed all required safety evaluations; or who received panobinostat. | Posted | Number | Participants | Cycle 1 (28-day treamtent cycle) |
|
|
|
| Secondary | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease. | Full Analysis Set: defined according to the Intention to Treat (ITT) principle. This population set included all patients to whom study treatment had been assigned. | Posted | Number | Participants | 3.5 years |
|
|
|
| Secondary | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase | Stage 2 did not open for enrollment. | Full Analysis Set. Response as per investigator assessment for a subset of patients with AML accrued in the expansion phase (IA) include complete response, progressive disease/failure, stable disease. | Posted | Number | Participants | 1.2 years |
|
|
|
| Secondary | Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) | Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure. | Full Analysis Set | Posted | Number | Participants | 3.5 years |
|
|
|
| Secondary | Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) | Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission. | Full Analysis Set | Posted | Number | Participants | 3.5 years |
|
|
|
| Secondary | Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2 | Pharmacokinetic set: Pharmacokinetic population consisted of all patients who provided at least one postdose PK plasma sample. | Posted | Mean | Standard Deviation | ng/mL | Day 1 |
|
|
|
| Secondary | Half Life of Panobinostat After the First Dose in Arms 1 and 2 | Pharmacokinetic set | Posted | Mean | Standard Deviation | hour | Day 1 |
|
|
|
| Secondary | Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15 | From day 15 by dose with schedule: MWF every week | Pharmacokinetic set | Posted | Mean | Standard Deviation | ng/mL | Day 15 |
|
|
|
| Secondary | Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15 | Pharmacokinetic set | Posted | Mean | Standard Deviation | hour | Day 15 |
|
|
|
| Secondary | Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 | MWF Every week schedule n = number of subjects with non-missing values. | Pharmacokinetic set | Posted | Geometric Mean | 90% Confidence Interval | Ratio | Day 15/day 1 |
|
|
|
| Secondary | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Reporting the number of patients with a reading at the timepoint in the dose group. | Full Analysis Set N=number of participants analyzed. total n=number of patients with a reading at the timepoint in the dose group. | Posted | Number | Percentages of participants | Days 1, 5, 8, 10, 15 |
|
|
|
| Secondary | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | Full Analysis Set | Posted | Number | Percentages of participants | Days 5, 8, end of study (up to 3.5 years) |
|
|
|
| Secondary | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Full Analysis Set | Posted | Number | Percentages of participants | Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years) |
|
|
|
| Secondary | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Full Analysis Set | Posted | Number | Percentages of participants | Days 5, 8, 10, 12, 15, End of study (up to 3.5 years) |
|
|
|
| Secondary | Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) | All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours])) | Full Analysis Set (with available samples for analysis) | Posted | Mean | Standard Deviation | Percent Change | Post dose to pre-dose (up to 3.5 years) |
|
|
|
| Secondary | Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week) | All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours])) | Full Analysis Set (with available samples for analysis) | Posted | Mean | Standard Deviation | Percent Change | Post dose to pre-dose (up to 3.5 years) |
|
|
|
| 8 |
| 8 |
| 8 |
| 8 |
| EG001 | Arm1, Group X (30 mg) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | 5 | 8 | 8 | 8 |
| EG002 | Arm1, Group X (40 mg) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | 9 | 10 | 10 | 10 |
| EG003 | Arm1 GroupX 60 mg | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | 34 | 49 | 49 | 49 |
| EG004 | Arm1 GroupX 80 mg | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | 10 | 11 | 11 | 11 |
| EG005 | Arm1 GroupY 20 mg | Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | 0 | 1 | 1 | 1 |
| EG006 | Arm1 GroupY 30 mg | Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | 3 | 4 | 4 | 4 |
| EG007 | Arm1 GroupY 40 mg | Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | 10 | 24 | 24 | 24 |
| EG008 | Arm1 GroupY 60 mg | Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | 2 | 5 | 5 | 5 |
| EG009 | Arm2 GroupX 30 mg | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | 5 | 6 | 6 | 6 |
| EG010 | Arm2 GroupX 45 mg | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | 8 | 9 | 9 | 9 |
| EG011 | Arm2 GroupX 60 mg | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | 7 | 9 | 9 | 9 |
| EG012 | Arm2 GroupX 80 mg | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | 8 | 9 | 9 | 9 |
| EG013 | Arm2 GroupY 30 mg | Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | 0 | 1 | 1 | 1 |
| EG014 | Arm2 GroupY 45 mg | Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | 3 | 7 | 7 | 7 |
| EG015 | Arm2 GroupY 60 mg | Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | 11 | 15 | 15 | 15 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Femoral hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Catheter related complication | General disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Alpha haemolytic streptococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Arthritis viral | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Catheter sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Enterococcal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Neutropenic infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Penile abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Perirectal abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia fungal | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA | Systematic Assessment |
|
| Serratia infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Transfusion-related circulatory overload | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
|
| Cardiac electrophysiologic study abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Troponin I increased | Investigations | MedDRA | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Fluid imbalance | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myofascitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Leukaemic infiltration brain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Leukostasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Tumour lysis syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Leukoencephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Dyspareunia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Diffuse alveolar damage | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Catheter removal | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Hypoprothrombinaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Splenic infarction | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Spontaneous haematoma | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Dilatation ventricular | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Antithrombin III deficiency | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Deafness bilateral | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Hyperacusis | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Cushingoid | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Thyroid disorder | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA | Systematic Assessment |
|
| Hyphaema | Eye disorders | MedDRA | Systematic Assessment |
|
| Keratoconjunctivitis sicca | Eye disorders | MedDRA | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA | Systematic Assessment |
|
| Ocular icterus | Eye disorders | MedDRA | Systematic Assessment |
|
| Pupillary disorder | Eye disorders | MedDRA | Systematic Assessment |
|
| Visual Impairment | Eye disorders | MedDRA | Systematic Assessment |
|
| Visual disturbance | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Caecitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gingival disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Lip haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oral discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oral mucosal petechiae | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pancreatic calcification | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Saliva altered | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Stomatitis haemorrhagic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Tongue coated | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Tongue discolouration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Catheter related complication | General disorders | MedDRA | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedDRA | Systematic Assessment |
|
| Catheter site oedema | General disorders | MedDRA | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA | Systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Chronic fatigue syndrome | General disorders | MedDRA | Systematic Assessment |
|
| Cyst | General disorders | MedDRA | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA | Systematic Assessment |
|
| Hypothermia | General disorders | MedDRA | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Mass | General disorders | MedDRA | Systematic Assessment |
|
| Mucosal haemorrhage | General disorders | MedDRA | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Oedema mucosal | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Pitting oedema | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Sensation of blood flow | General disorders | MedDRA | Systematic Assessment |
|
| Thirst decreased | General disorders | MedDRA | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Immunodeficiency | Immune system disorders | MedDRA | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Anal candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Aspergillosis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Candida pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Catheter sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Condyloma acuminatum | Infections and infestations | MedDRA | Systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
|
| Enterobacter bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Enterobacter infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Enterococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Enterococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Enterococcal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Klebsiella bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Klebsiella sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Micrococcal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pilonidal cyst | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia fungal | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pseudomonal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Streptococcal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Haemothorax | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Activated partial thromboplastin time shortened | Investigations | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Anaemia | Investigations | MedDRA | Systematic Assessment |
|
| Anti-erythrocyte antibody positive | Investigations | MedDRA | Systematic Assessment |
|
| Antithrombin III decreased | Investigations | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Aspiration biopsy | Investigations | MedDRA | Systematic Assessment |
|
| Biopsy skin | Investigations | MedDRA | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood bicarbonate decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood fibrinogen increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood sodium increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA | Systematic Assessment |
|
| Clostridium difficile toxin test positive | Investigations | MedDRA | Systematic Assessment |
|
| Computerised tomogram abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA | Systematic Assessment |
|
| Electrocardiogram QRS complex prolonged | Investigations | MedDRA | Systematic Assessment |
|
| Electrocardiogram QT corrected interval prolonged | Investigations | MedDRA | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA | Systematic Assessment |
|
| Electrocardiogram ST segment abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Electrocardiogram ST segment depression | Investigations | MedDRA | Systematic Assessment |
|
| Electrocardiogram ST-T change | Investigations | MedDRA | Systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Electrocardiogram repolarisation abnormality | Investigations | MedDRA | Systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA | Systematic Assessment |
|
| Fungus stool identified | Investigations | MedDRA | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Glomerular filtration rate decreased | Investigations | MedDRA | Systematic Assessment |
|
| Hypophosphataemia | Investigations | MedDRA | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA | Systematic Assessment |
|
| Oxygen saturation increased | Investigations | MedDRA | Systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA | Systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA | Systematic Assessment |
|
| Prothrombin time shortened | Investigations | MedDRA | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Folate deficiency | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Iron overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Podagra | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Vitamin B6 deficiency | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Periostitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Tumour lysis syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Coordination abnormal | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Facial palsy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypokinesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Meningeal disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Monoparesis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Peripheral paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Sensory loss | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Ketonuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urethral pain | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Breast swelling | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Penile pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypocapnia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory alkalosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory gas exchange disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA | Systematic Assessment |
|
| Orthostatic hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Venoocclusive disease | Vascular disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigators from publishing. Any publications from a single-site are postponed until the publication of the polled data (ie, data from all sites) in the clinical trial.
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D006880 |
| Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Stable disease (SD) |
|
| Progressive disease (PD)/failure |
|
| Not evaluable |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Not evaluable |
|
| Missing |
|
| Stable disease (SD) |
|
| Progressive disease (PD)/failure |
|
| Missing |
|
| Progressive disease (PD)/failure |
|
| Missing |
|
| Partial remission (PR) |
|
| C (max) N=8,12,18,17,4 |
|
| Day 5 (total = 6, 4, 8, 17, 8) |
|
| Day 8 (total = 5, 4, 8, 17, 7) |
|
| Day 10 (total=0, 0, 0, 0, 0, 1) |
|
| Day 15 (total=3, 3, 4, 2, 2) |
|
| Day 8 (total = 1, 3, 11, 4) |
|
| End of Study (total=1, 0, 0, 0) |
|
| Day 8 (total = 4, 7, 5, 7) |
|
| Day 10 (Total=3, 8, 5, 7) |
|
| Day 12 (Total=4, 6, 4, 8) |
|
| Day 15 (Total=4, 6, 2, 5) |
|
| End of Study (Total=1, 4, 2, 0) |
|
| Unscheduled (Total=2, 0, 0, 0) |
|
|
| Day 10 (total=1, 4, 5) |
|
| Day 12 (Total=0, 3, 5) |
|
| Day 15 (Total=1, 3, 5) |
|
| End of Study (Total=0, 2, 0) |
|