Multicenter, Open-label, Clinical and Pharmacokinetic Stu... | NCT02533674 | Trialant
NCT02533674
Sponsor
PharmaMar
Status
Completed
Last Update Posted
Jun 11, 2021Actual
Enrollment
57Actual
Phase
Phase 1
Conditions
Solid Tumors
Interventions
Gemcitabine plus PM060184
Countries
United States
Spain
Protocol Section
Identification Module
NCT ID
NCT02533674
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PM60184-A-003-14
Secondary IDs
ID
Type
Description
Link
PM60184-A-003-14
Other Identifier
Pharma Mar USA, Inc.
2014-002943-16
EudraCT Number
Brief Title
Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM060184 in Combination With Gemcitabine in Selected Patients With Advanced Solid Tumors
Official Title
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM060184 in Combination With Gemcitabine in Selected Patients With Advanced Solid Tumors
Acronym
Not provided
Organization
PharmaMarINDUSTRY
Status Module
Record Verification Date
May 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 12, 2014Actual
Primary Completion Date
Jul 11, 2019Actual
Completion Date
Jul 11, 2019Actual
First Submitted Date
Aug 7, 2015
First Submission Date that Met QC Criteria
Aug 24, 2015
First Posted Date
Aug 27, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 10, 2021
Results First Submitted that Met QC Criteria
Apr 20, 2021
Results First Posted Date
May 13, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 17, 2021
Last Update Posted Date
Jun 11, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PharmaMarINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Prospective, open-label, dose-ranging, uncontrolled phase I study with escalating doses of PM060184 in combination with gemcitabine in selected patients with advanced solid tumors.
The study objectives are:
To determine the MTD and the RD of PM060184 in combination with gemcitabine in selected patients with advanced solid tumors.
To characterize the safety profile and feasibility of this combination in this study population.
To characterize the pharmacokinetics of this combination and to detect major drug-drug PK interactions.
To obtain preliminary information on the clinical antitumor activity of this combination.
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumors
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
57Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
gemcitabine plus PM060184
Experimental
Drug: Gemcitabine plus PM060184
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Gemcitabine plus PM060184
Drug
gemcitabine plus PM060184
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities
Dose-limiting toxicities were defined as:
Grade 4 neutropenia lasting >3 days
Grade≥3 febrile neutropenia of any duration or neutropenic sepsis
Grade 4 thrombocytopenia or grade 3 with any major bleeding episode requiring a platelet transfusion
Grade 4 ALT/AST increase, or grade 3 lasting >7 days
Treatment-related grade≥2 ALT/AST increase concomitantly with ≥2 x ULN total bilirubin increase and normal AP
Any other grade≥3 non-hematological AE that was suspected to be related to study drugs, except nausea/vomiting, hypersensitivity reactions, extravasations, grade 3 asthenia lasting less than one week, anorexia, and non-clinically relevant isolated biochemical abnormalities
Delay in the administration of Cycle 2 of the combination exceeding seven (+1) days of the treatment due date due to any AEs related to study drugs.
The following circumstances were to be discussed between the Principal Investigator and the Sponsor, and the final consensus had to be documented
From the start of treatment to the end of cycle one which are 3 weeks
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Clinical Benefit
Clinical benefit defined as any response or stable disease ≥4 months. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Voluntarily signed and dated written informed consent prior to any specific study procedure.
Age ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 1 (see APPENDIX 1).
Life expectancy ≥ 3 months.
Patients with a histologically/cytologically confirmed diagnosis of advanced disease of any of the following tumors that progressed to standard therapy or for whom no standard therapy exists:
Breast cancer non-candidate for hormone therapy alone.
Locally advanced or metastatic head and neck cancer.
Non-small cell lung cancer (NSCLC).
Germ cell tumors (GCTs).
Biliary tract adenocarcinoma.
Adenocarcinoma or carcinoma of unknown primary site (UKPS).
Cervix carcinoma.
Gastrointestinal stromal tumor (GIST).
Urothelial cancer.
Expansion cohort at the RD:
All patients must have:
Measurable disease according to RECIST v.1.1 (or Choi criteria and/or EORTC metabolic response criteria for solid tumors, in the case of GIST); or
Evaluable disease by serum markers in the case of ovarian cancer [Gynecologic Cancer Intergroup (GCIG) specific criteria]; and
Documented disease progression during or immediately after last therapy according to any of the aforementioned criteria.
Wash-out periods: at least three weeks since the last anticancer therapy, including radiation therapy (RT) in more than 35% of the bone marrow; at least three weeks since the last biological/investigational therapy [excluding monoclonal antibodies (MAbs)]; at least four weeks since the last MAb-containing therapy; and at least six weeks since nitrosoureas and mitomycin C (systemic). In the case of hormonesensitive breast cancer progressing while on hormone therapy, the latter must be either stopped up to one week before or continued without changes during the trial.
Adequate bone marrow, renal, hepatic, and metabolic function (assessed ≤ 7 days before inclusion in the study):
Platelet count ≥ 100 x 109/l, hemoglobin ≥ 9.0 g/dl and ANC ≥ 1.0 x 109/l.
AST and ALT ≤ 3.0 x ULN, independently of the presence of liver metastases.
AP ≤ 2.5 x ULN (≤ 5 x ULN if disease-related).
Total bilirubin ≤ 1.5 x ULN.
International Normalized Ratio (INR) < 1.5 (except if patient is on oral anticoagulation therapy).
Calculated creatinine clearance (CrCl) ≥ 50 ml/minute (using Cockcroft and Gault's formula; see APPENDIX 2).
Albumin ≥ 2.5 g/dl.
Recovery to grade ≤ 1 from any AE derived from previous treatment (excluding alopecia and/or cutaneous toxicity and/or asthenia).
Left ventricular ejection fraction (LVEF) by echocardiography (ECHO) or multiplegated acquisition (MUGA) within normal range (according to institutional standards).
Women of childbearing potential must have a negative serum or urine pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six weeks after discontinuation of treatment. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant and/or double barrier.
Exclusion Criteria:
Concomitant diseases/conditions:
History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
Known chronic active hepatitis or cirrhosis
Active uncontrolled infection [i.e., antibiotic, antifungal or antiviral intervention indicated or surgical procedure (i.e., pleural or deep abscess drainage) conducted within 15 days prior to inclusion].
Known human immunodeficiency virus (HIV) infection.
Current or prior history of grade ≥ 2 peripheral sensory and/or motor neuropathy.
Prior treatment with oxaliplatin.
Limitation of the patient's ability to comply with the treatment or follow-up protocol.
Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
Symptomatic, progressive or corticosteroids-requiring documented brain metastases or leptomeningeal disease involvement.
Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.
Patients who have had RT in more than 35% of the bone marrow.
Treatment with any investigational product within 30 days before the first infusion.
Prior treatment with PM060184.
Prior treatment with gemcitabine-containing therapy for advanced disease (adjuvant therapy is allowed, provided not more than six cycles were administered and relapse occurred more than six months after the last drug administration), and/or:
Patients who have previously discontinued gemcitabine-containing regimens due to gemcitabine-related toxicity.
Known hypersensitivity to gemcitabine or any component of the formulation.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
New York
New York
10461
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
A total of 57 patients were enrolled at three investigational sites, and 55 patients were treated with the GEM/PM060184 combination. Two patients were never treated.
Patients participated in this trial between 12 December 2014 and 11 July 2019 (last follow-up). The first dose of the first cycle was given on 10 February 2015 and the last dose of the last cycle was given on 7 June 2019.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
GEM/PM060184 Dose Level I
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Every two cycles (every six weeks ± one week) until Cycle 4, and then every three cycles (every nine weeks ± one week) while on treatment, up to 2 years
Madrid
Spain
FG001
GEM/PM060184 Dose Level II
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
ECOG PS, Eastern Cooperative Oncology Group performance status PS 0 Fully active able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities up and about more than 50% of waking hours PS 3 Capable of only limited selfcare confined to bed or chair more than 50% of waking hours PS 4 Completely disabled cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
0
BG0001
BG001
Body surface area
Median
Full Range
m^2
Title
Denominators
Categories
Title
Measurements
BG0001.6(1.4 to 2.0)
BG0011.7(1.5 to 1.9)
BG002
Tumor type
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
NSCLC
BG0003
BG0015
BG002
Time from diagnosis to first infusion
Median
Full Range
months
Title
Denominators
Categories
Title
Measurements
BG00030.2(10.9 to 58.4)
BG00143.0(7.3 to 76.3)
BG002
Time from last progressive disease to first infusion
Median
Full Range
months
Title
Denominators
Categories
Title
Measurements
BG0001.6(0.9 to 2.0)
BG0011.0(0.3 to 2.2)
BG002
Time-to-progression of last prior therapy
Median
Full Range
months
Title
Denominators
Categories
Title
Measurements
BG0001.6(0.9 to 18.4)
BG0013.8(1.4 to 18.2)
BG002
Bulky disease
Bulky disease is defined as any target lesion measuring at least 50 mm
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
BG0001
BG0011
BG002
Site involvement at baseline
Median
Full Range
sites
Title
Denominators
Categories
Title
Measurements
BG0003(2 to 5)
BG0014(2 to 5)
BG002
Lines of prior anticancer therapies
Median
Full Range
lines
Title
Denominators
Categories
Title
Measurements
BG0002(1 to 5)
BG0013(1 to 6)
BG002
Agents of prior anticancer therapies
Median
Full Range
Agents
Title
Denominators
Categories
Title
Measurements
BG0004(2 to 6)
BG0014(2 to 7)
BG002
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 With Dose Limiting Toxicities
Dose-limiting toxicities were defined as:
Grade 4 neutropenia lasting >3 days
Grade≥3 febrile neutropenia of any duration or neutropenic sepsis
Grade 4 thrombocytopenia or grade 3 with any major bleeding episode requiring a platelet transfusion
Grade 4 ALT/AST increase, or grade 3 lasting >7 days
Treatment-related grade≥2 ALT/AST increase concomitantly with ≥2 x ULN total bilirubin increase and normal AP
Any other grade≥3 non-hematological AE that was suspected to be related to study drugs, except nausea/vomiting, hypersensitivity reactions, extravasations, grade 3 asthenia lasting less than one week, anorexia, and non-clinically relevant isolated biochemical abnormalities
Delay in the administration of Cycle 2 of the combination exceeding seven (+1) days of the treatment due date due to any AEs related to study drugs.
The following circumstances were to be discussed between the Principal Investigator and the Sponsor, and the final consensus had to be documented
Thirteen patients were not evaluable: 11 patients because they did not complete Cycle 1, and two patients because they were withdrawn from the study before receiving the first study drug infusion.
Posted
Count of Participants
Participants
From the start of treatment to the end of cycle one which are 3 weeks
ID
Title
Description
OG000
GEM/PM060184 Dose Level I
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Clinical benefit defined as any response or stable disease ≥4 months. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Eleven patients were not evaluable: nine patients because they were withdrawn from the study before undergoing a tumor assessment, and two patients because they were withdrawn from the study before receiving the first study drug infusion
Posted
Count of Participants
Participants
Every two cycles (every six weeks ± one week) until Cycle 4, and then every three cycles (every nine weeks ± one week) while on treatment, up to 2 years
ID
Title
Description
OG000
GEM/PM060184 Dose Level I
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Asthenia
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected7 at risk
EG0025 events1 affected4 at risk
EG003
Fatigue
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG00111 events5 affected7 at risk
EG0028 events3 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Catheter site erythema
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Local swelling
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Chest discomfort
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Gait disturbance
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pain
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Chills
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Feeling of body temperature change
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Infusion site discolouration
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Malaise
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Oedema
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Catheter site pain
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Depression
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Vulvovaginal pain
Reproductive system and breast disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0023 events1 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Weight decreased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Blood urine present
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Weight increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0002 events2 affected4 at risk
EG0014 events2 affected7 at risk
EG0023 events2 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0003 events3 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Normochromic normocytic anaemia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0022 events1 affected4 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0012 events1 affected7 at risk
EG00212 events1 affected4 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Tremor
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Cataract
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dry eye
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Vitreous detachment
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Eye pain
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0014 events2 affected7 at risk
EG0022 events1 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0007 events2 affected4 at risk
EG0017 events5 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0014 events3 affected7 at risk
EG0022 events1 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Enterovesical fistula
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Tooth loss
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Urethritis noninfective
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0022 events1 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Wound infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Conjunctivitis viral
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Cystitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Device related infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
Point of Contact
Title
Organization
Phone
Extension
Email
Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.