PCYC-0403: Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma
Sponsor
Pharmacyclics LLC. (Industry)
Overall Status
Completed
CT.gov ID
NCT00724984
Collaborator
(none)
55
8
1
6.9
Study Details
Study Description
Brief Summary
The first part of the study will determine the highest dose of study drug that can be taken without causing serious side effects in patients with lymphoma. The appropriate dose determined from the first part of the study will be used in the second part of the study to assess disease response in 2 different types of lymphoma patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
55 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II Dose-Escalation Study of the Pan-Histone Deacetylase (HDAC) Inhibitor PCI-24781 in Lymphoma
Study Start Date
:
Jul 1, 2008
Actual Primary Completion Date
:
Nov 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: PCI-24781
Phase I Dose Escalation: Up to 5 cohorts will receive PCI-24781 orally at doses starting at 30mg/m2 two times a day approximately 4-6 hours apart ("BID"), up to 90mg/m2 administered 5 days/week during the first 21 days of each 28 day cycle until the maximum tolerated dose (MTD) is reached. If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle).
Phase II Efficacy Evaluation: All patients will receive PCI-24781 orally at the dosage and regimen determined in Phase I.
|
Outcome Measures
Primary Outcome Measures
- Phase I (Dose Escalation Phase): MTD and DLTs of PCI-24781 Administered Twice Daily (BID) Measure: Disease Response [From the Date of PCI-24781 first administration to Cycle 2 Day 1]
Number of patients experienced DLT in each cohort
- Phase II: Overall Response Rate (CR+PR) [From first response assessment (day 22 to 28 of Cycle 2) to last response assessment on day 22-28 in even-numbered cycles]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
• age ≥ 18 years
-
Phase I: Any measurable, histologically confirmed, and previously treated lymphoma
-
Phase II: Measurable, histologically confirmed, and previously treated lymphoma in one of the following categories:
-
Follicular non-Hodgkin's Lymphoma
-
Mantle cell lymphoma
-
Ability to swallow oral capsules without difficulty
-
Estimated life expectancy > 12 weeks
-
ECOG performance status ≤ 1
-
Willing and able to sign a written informed consent
Exclusion Criteria:
-
• More than four prior systemic treatment regimens (not counting maintenance rituximab; salvage therapy/conditioning regimen preceding autologous bone marrow transplantation [ABMT] and ABMT count as one regimen)
-
Allogeneic bone marrow transplant
-
Immunotherapy, chemotherapy, radiotherapy or experimental therapy within 4 weeks before first day of study drug dosing
-
Major surgery within 4 weeks before first day of study drug dosing
-
CNS lymphoma or a history of meningeal carcinomatosis
-
Prior treatment with an HDAC inhibitor (unless for treatment of Mycosis fungoides or Sézary syndrome)
-
Creatinine > 1.5 x institutional upper limit of normal (ULN) or creatinine clearance ≤ 50 mL/min
-
Total bilirubin > 1.5 x institutional ULN (unless elevated from documented Gilbert's syndrome)
-
AST and ALT > 2.5 x institutional ULN
-
Platelet count < 75,000/µL for Phase I and <100,000>µL for Phase II
-
Absolute neutrophil count (ANC) < 1500/µL
-
Malabsorption
-
Corticosteroids > 20 mg prednisone equivalent per day (topical, inhaled, or nasal corticosteroids are permitted)
-
Concurrent therapeutic anticoagulation (Phase I only)
-
Uncontrolled illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements
-
Risk factors for, or use of drugs known to prolong QTc interval or that may be associated
-
QTc prolongation (defined as a QTc ≥ 450 msecs) or other significant ECG abnormalities including 2nd degree AV block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min). If the screening ECG has a QTc ≥ 450 msecs, the ECG can be submitted for a centralized, cardiologic evaluation.
-
History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within the past 6 months.
-
For patients with history of myocardial infarction, congestive heart failure, abnormal left ventricular ejection fraction (LVEF), and/or prior anthracycline exposure, LVEF < 50%, as assessed by ventriculography (nuclear or heart catheterization) or echocardiogram, when performed within 28 days of first dose of study drug.
-
For patients with history of coronary artery disease, a cardiac stress test (either exercise or pharmacologic) that demonstrates clinically significant abnormalities when performed within 28 days of first dose of study drug.
-
Known HIV infection.
-
Other medical or psychiatric illness or organ dysfunction which, in the opinion of the investigator, would either compromise the patient's safety or interfere with the evaluation of the safety of the study agent.
-
Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound).
-
Women of child-bearing potential, or sexually active men, unwilling to use adequate contraceptive protection during the course of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Francisco | San Francisco | California | United States | 94143 |
| 2 | Northwestern University Medical School | Chicago | Illinois | United States | 60611 |
| 3 | Horizon Oncology Center | Lafayette | Indiana | United States | 47905 |
| 4 | University of Massachusetts Medical School | Worcester | Massachusetts | United States | 01655 |
| 5 | Washington University School of Medicine | St. Louis | Missouri | United States | 63110 |
| 6 | Nebraska Methodist Hospital | Omaha | Nebraska | United States | 68114 |
| 7 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
| 8 | University of Vermont and Fletcher Allen Health Care | Burlington | Vermont | United States | 05405 |
Sponsors and Collaborators
- Pharmacyclics LLC.
Investigators
- Study Director: Thorsten Graef, MD, Pharmacyclics LLC.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT00724984
Other Study ID Numbers:
- PCYC-0403
First Posted:
Jul 30, 2008
Last Update Posted:
Apr 7, 2014
Last Verified:
Feb 1, 2014
Keywords provided by Pharmacyclics LLC.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cohort 1(30mg/m2,5days/wk)/Phase 1 | Cohort 2(45mg/m2,5days/wk)/Phase 1 | Cohort 3(45mg/m2,7days/wk)/Phase 1 | Cohort 4(60mg/m2,7days/wk)/Phase 1 | Follicular/Phase II | Mantle Cell Lymphoma/Phase II |
|---|---|---|---|---|---|---|
| Arm/Group Description | ||||||
| Period Title: Overall Study | ||||||
| STARTED | 5 | 8 | 3 | 9 | 16 | 14 |
| COMPLETED | 4 | 7 | 3 | 7 | 12 | 9 |
| NOT COMPLETED | 1 | 1 | 0 | 2 | 4 | 5 |
Baseline Characteristics
| Arm/Group Title | Cohort 1(30 mg/m2, 5days/wk)/Phase 1 | Cohort 2(45 mg/m2, 5days/wk)/Phase 1 | Cohort 3(45 mg/m2, 7days/wk)/Phase 1 | Cohort 4(60 mg/m2,7days/wk)/Phase 1 | Follicular/Phase II | Mantle Cell Lymphoma/Phase II | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||||||
| Overall Participants | 5 | 8 | 3 | 9 | 16 | 14 | 55 |
| Age (years) [Median (Full Range) ] | |||||||
| Median (Full Range) [years] |
68
|
67
|
62
|
66
|
62
|
67
|
66
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
1
20%
|
5
62.5%
|
1
33.3%
|
3
33.3%
|
8
50%
|
12
85.7%
|
30
54.5%
|
| Male |
4
80%
|
3
37.5%
|
2
66.7%
|
6
66.7%
|
8
50%
|
2
14.3%
|
25
45.5%
|
| Region of Enrollment (participants) [Number] | |||||||
| United States |
5
100%
|
8
100%
|
3
100%
|
9
100%
|
16
100%
|
14
100%
|
55
100%
|
Outcome Measures
| Title | Phase I (Dose Escalation Phase): MTD and DLTs of PCI-24781 Administered Twice Daily (BID) Measure: Disease Response |
|---|---|
| Description | Number of patients experienced DLT in each cohort |
| Time Frame | From the Date of PCI-24781 first administration to Cycle 2 Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cohort 1(30 mg/m2, BID, 5days/wk)/Phase I | Cohort 2(45 mg/m2, BID, 5days/wk)/Phase I | Cohort 3(45 mg/m2, BID, 7days/wk)/Phase I | Cohort 4(60 mg/m2, BID, 7days/wk)/Phase I |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 3 | 7 | 3 | 8 |
| Number [participants] |
0
0%
|
3
37.5%
|
0
0%
|
2
22.2%
|
| Title | Phase II: Overall Response Rate (CR+PR) |
|---|---|
| Description | |
| Time Frame | From first response assessment (day 22 to 28 of Cycle 2) to last response assessment on day 22-28 in even-numbered cycles |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Follicular/Phase II (Efficacy) | Mantle Cell Lymphoma/Phase II (Efficacy) |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 16 | 14 |
| Number (95% Confidence Interval) [Percentage of Participants] |
56.3
1126%
|
21.4
267.5%
|
Adverse Events
| Time Frame | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | Cohort 1(30 mg/m2, 5days/wk)/Phase I | Cohort 2(45 mg/m2, 5days/wk)/Phase I | Cohort 3(45 mg/m2, 7days/wk)/Phase I | Cohort 4(60 mg/m2,7days/wk)/Phase I | Follicular/Phase II | Mantle Cell Lymphoma/Phase II | ||||||
| Arm/Group Description | ||||||||||||
All Cause Mortality |
||||||||||||
| Cohort 1(30 mg/m2, 5days/wk)/Phase I | Cohort 2(45 mg/m2, 5days/wk)/Phase I | Cohort 3(45 mg/m2, 7days/wk)/Phase I | Cohort 4(60 mg/m2,7days/wk)/Phase I | Follicular/Phase II | Mantle Cell Lymphoma/Phase II | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| Cohort 1(30 mg/m2, 5days/wk)/Phase I | Cohort 2(45 mg/m2, 5days/wk)/Phase I | Cohort 3(45 mg/m2, 7days/wk)/Phase I | Cohort 4(60 mg/m2,7days/wk)/Phase I | Follicular/Phase II | Mantle Cell Lymphoma/Phase II | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/5 (60%) | 1/8 (12.5%) | 0/3 (0%) | 3/9 (33.3%) | 6/16 (37.5%) | 5/14 (35.7%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| ANAEMIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| Cardiac disorders | ||||||||||||
| ATRIAL FIBRILLATION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| ABDOMINAL PAIN | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 0/14 (0%) | ||||||
| DIARRHOEA | 1/5 (20%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| HAEMORRHOIDAL HAEMORRHAGE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| LOWER GASTROINTESTINAL HAEMORRHAGE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| MELAENA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| NAUSEA | 1/5 (20%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| SMALL INTESTINAL OBSTRUCTION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| VOMITING | 1/5 (20%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| General disorders | ||||||||||||
| FATIGUE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| PERFORMANCE STATUS DECREASED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| PYREXIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 0/14 (0%) | ||||||
| Infections and infestations | ||||||||||||
| ANAL ABSCESS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 0/14 (0%) | ||||||
| ANAL INFECTION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 0/14 (0%) | ||||||
| CELLULITIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| SINUSITIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| VIRAL INFECTION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| Investigations | ||||||||||||
| BLOOD CREATININE INCREASED | 1/5 (20%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| DEHYDRATION | 1/5 (20%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| HYPOGLYCAEMIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| BACK PAIN | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| FLANK PAIN | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 0/14 (0%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| CANCER PAIN | 1/5 (20%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| LYMPHOMA | 1/5 (20%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| NEOPLASM MALIGNANT | 1/5 (20%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| ENCEPHALITIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| Psychiatric disorders | ||||||||||||
| MENTAL STATUS CHANGES | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| Renal and urinary disorders | ||||||||||||
| ANURIA | 1/5 (20%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| NEPHROLITHIASIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| RENAL FAILURE ACUTE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 0/14 (0%) | ||||||
| Reproductive system and breast disorders | ||||||||||||
| PELVIC PAIN | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 0/14 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| PULMONARY EMBOLISM | 1/5 (20%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| Cohort 1(30 mg/m2, 5days/wk)/Phase I | Cohort 2(45 mg/m2, 5days/wk)/Phase I | Cohort 3(45 mg/m2, 7days/wk)/Phase I | Cohort 4(60 mg/m2,7days/wk)/Phase I | Follicular/Phase II | Mantle Cell Lymphoma/Phase II | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/5 (100%) | 8/8 (100%) | 3/3 (100%) | 9/9 (100%) | 16/16 (100%) | 13/14 (92.9%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| ANAEMIA | 1/5 (20%) | 1/8 (12.5%) | 0/3 (0%) | 2/9 (22.2%) | 4/16 (25%) | 4/14 (28.6%) | ||||||
| LEUKOPENIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 1/14 (7.1%) | ||||||
| LYMPH NODE PAIN | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| LYMPHOPENIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| NEUTROPENIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 2/9 (22.2%) | 4/16 (25%) | 3/14 (21.4%) | ||||||
| THROMBOCYTOPENIA | 0/5 (0%) | 4/8 (50%) | 0/3 (0%) | 2/9 (22.2%) | 10/16 (62.5%) | 4/14 (28.6%) | ||||||
| Cardiac disorders | ||||||||||||
| PALPITATIONS | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| SINUS TACHYCARDIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| Ear and labyrinth disorders | ||||||||||||
| EAR PAIN | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 0/14 (0%) | ||||||
| Endocrine disorders | ||||||||||||
| HYPOTHYROIDISM | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| Eye disorders | ||||||||||||
| CONJUNCTIVAL HAEMORRHAGE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| CONJUNCTIVITIS | 0/5 (0%) | 0/8 (0%) | 1/3 (33.3%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| DRY EYE | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| EYE SWELLING | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| EYELID IRRITATION | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| LACRIMATION INCREASED | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| MIOSIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| VISUAL ACUITY REDUCED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| ABDOMINAL DISTENSION | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 1/14 (7.1%) | ||||||
| ABDOMINAL PAIN | 2/5 (40%) | 4/8 (50%) | 0/3 (0%) | 0/9 (0%) | 3/16 (18.8%) | 2/14 (14.3%) | ||||||
| ABDOMINAL PAIN UPPER | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| APHTHOUS STOMATITIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| CHAPPED LIPS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| CONSTIPATION | 1/5 (20%) | 1/8 (12.5%) | 0/3 (0%) | 1/9 (11.1%) | 7/16 (43.8%) | 3/14 (21.4%) | ||||||
| DIARRHOEA | 0/5 (0%) | 3/8 (37.5%) | 0/3 (0%) | 5/9 (55.6%) | 8/16 (50%) | 7/14 (50%) | ||||||
| DRY MOUTH | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 0/14 (0%) | ||||||
| DYSPEPSIA | 0/5 (0%) | 2/8 (25%) | 0/3 (0%) | 0/9 (0%) | 3/16 (18.8%) | 1/14 (7.1%) | ||||||
| ERUCTATION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| FLATULENCE | 0/5 (0%) | 0/8 (0%) | 1/3 (33.3%) | 0/9 (0%) | 2/16 (12.5%) | 2/14 (14.3%) | ||||||
| FREQUENT BOWEL MOVEMENTS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| GASTROOESOPHAGEAL REFLUX DISEASE | 0/5 (0%) | 2/8 (25%) | 0/3 (0%) | 0/9 (0%) | 4/16 (25%) | 1/14 (7.1%) | ||||||
| GLOSSODYNIA | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| NAUSEA | 0/5 (0%) | 3/8 (37.5%) | 1/3 (33.3%) | 2/9 (22.2%) | 11/16 (68.8%) | 7/14 (50%) | ||||||
| RECTAL HAEMORRHAGE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| RETCHING | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| STOMATITIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 3/16 (18.8%) | 1/14 (7.1%) | ||||||
| TOOTHACHE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| VOMITING | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 2/9 (22.2%) | 7/16 (43.8%) | 3/14 (21.4%) | ||||||
| General disorders | ||||||||||||
| CHEST DISCOMFORT | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| CHEST PAIN | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| CHILLS | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 1/9 (11.1%) | 1/16 (6.3%) | 5/14 (35.7%) | ||||||
| EARLY SATIETY | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| FATIGUE | 4/5 (80%) | 6/8 (75%) | 1/3 (33.3%) | 2/9 (22.2%) | 10/16 (62.5%) | 8/14 (57.1%) | ||||||
| INFLUENZA LIKE ILLNESS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| LOCALISED OEDEMA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| OEDEMA PERIPHERAL | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 1/9 (11.1%) | 2/16 (12.5%) | 5/14 (35.7%) | ||||||
| PAIN | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| PERFORMANCE STATUS DECREASED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| PYREXIA | 1/5 (20%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 3/16 (18.8%) | 1/14 (7.1%) | ||||||
| VESSEL PUNCTURE SITE HAEMATOMA | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| Hepatobiliary disorders | ||||||||||||
| HYPERBILIRUBINAEMIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| JAUNDICE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| Immune system disorders | ||||||||||||
| ALLERGY TO ARTHROPOD BITE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| SEASONAL ALLERGY | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| Infections and infestations | ||||||||||||
| CANDIDIASIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| CELLULITIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| FUNGAL INFECTION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| HERPES ZOSTER | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| INFECTED BITES | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| INFLUENZA | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| NASOPHARYNGITIS | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| OTITIS MEDIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| PNEUMONIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| PNEUMONIA KLEBSIELLA | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| SINUSITIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 2/16 (12.5%) | 4/14 (28.6%) | ||||||
| STAPHYLOCOCCAL SKIN INFECTION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| TOOTH INFECTION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| UPPER RESPIRATORY TRACT INFECTION | 1/5 (20%) | 0/8 (0%) | 2/3 (66.7%) | 0/9 (0%) | 3/16 (18.8%) | 2/14 (14.3%) | ||||||
| URINARY TRACT INFECTION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| VIRAL INFECTION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| ANIMAL BITE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 0/14 (0%) | ||||||
| ARTHROPOD BITE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| CONTUSION | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 0/14 (0%) | ||||||
| FALL | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| LACERATION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| PROCEDURAL PAIN | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| Investigations | ||||||||||||
| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 0/14 (0%) | ||||||
| ALANINE AMINOTRANSFERASE INCREASED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| ASPARTATE AMINOTRANSFERASE INCREASED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| BLOOD ALKALINE PHOSPHATASE INCREASED | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| BLOOD BICARBONATE DECREASED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| BLOOD CREATININE INCREASED | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| BLOOD LACTATE DEHYDROGENASE INCREASED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| BREATH SOUNDS ABNORMAL | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 0/14 (0%) | ||||||
| ELECTROCARDIOGRAM QT PROLONGED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| ELECTROCARDIOGRAM ST-T CHANGE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| HAEMOGLOBIN | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| HEART RATE INCREASED | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| INTERNATIONAL NORMALISED RATIO INCREASED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| PLATELET COUNT DECREASED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| TROPONIN INCREASED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| WEIGHT DECREASED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| WEIGHT INCREASED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| DECREASED APPETITE | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 2/9 (22.2%) | 4/16 (25%) | 3/14 (21.4%) | ||||||
| DEHYDRATION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 3/16 (18.8%) | 2/14 (14.3%) | ||||||
| HYPERGLYCAEMIA | 1/5 (20%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 3/16 (18.8%) | 2/14 (14.3%) | ||||||
| HYPERKALAEMIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| HYPERLIPIDAEMIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| HYPERNATRAEMIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| HYPERTRIGLYCERIDAEMIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 0/14 (0%) | ||||||
| HYPERURICAEMIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| HYPOALBUMINAEMIA | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 1/14 (7.1%) | ||||||
| HYPOCALCAEMIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 1/14 (7.1%) | ||||||
| HYPOKALAEMIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 1/14 (7.1%) | ||||||
| HYPOMAGNESAEMIA | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 1/9 (11.1%) | 3/16 (18.8%) | 1/14 (7.1%) | ||||||
| HYPONATRAEMIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| HYPOPHOSPHATAEMIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| INCREASED APPETITE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| ARTHRALGIA | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 2/14 (14.3%) | ||||||
| ARTHROPATHY | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| BACK PAIN | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 2/14 (14.3%) | ||||||
| CLUBBING | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| COSTOCHONDRITIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 0/14 (0%) | ||||||
| GROIN PAIN | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| JOINT STIFFNESS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 0/14 (0%) | ||||||
| JOINT SWELLING | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| LIMB DISCOMFORT | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| MUSCLE SPASMS | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 1/9 (11.1%) | 2/16 (12.5%) | 2/14 (14.3%) | ||||||
| MUSCULAR WEAKNESS | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 2/14 (14.3%) | ||||||
| MUSCULOSKELETAL CHEST PAIN | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| MUSCULOSKELETAL DISCOMFORT | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| MUSCULOSKELETAL PAIN | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| MYALGIA | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| NECK PAIN | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| PAIN IN EXTREMITY | 0/5 (0%) | 2/8 (25%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| PAIN IN JAW | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| SPINAL COLUMN STENOSIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| SQUAMOUS CELL CARCINOMA OF SKIN | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| TUMOUR PAIN | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| AREFLEXIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| ATAXIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| DIZZINESS | 0/5 (0%) | 3/8 (37.5%) | 0/3 (0%) | 2/9 (22.2%) | 3/16 (18.8%) | 1/14 (7.1%) | ||||||
| DYSGEUSIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 4/16 (25%) | 3/14 (21.4%) | ||||||
| HEADACHE | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 1/9 (11.1%) | 5/16 (31.3%) | 3/14 (21.4%) | ||||||
| HYPOAESTHESIA | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| HYPOGEUSIA | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| INTENTION TREMOR | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| LOSS OF CONSCIOUSNESS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| MEMORY IMPAIRMENT | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 2/9 (22.2%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| MIGRAINE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| MOTOR DYSFUNCTION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| NEUROPATHY PERIPHERAL | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| PARAESTHESIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| PAROSMIA | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| PERIPHERAL SENSORY NEUROPATHY | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 3/16 (18.8%) | 1/14 (7.1%) | ||||||
| TENSION HEADACHE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| TREMOR | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| Psychiatric disorders | ||||||||||||
| ANXIETY | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 2/16 (12.5%) | 1/14 (7.1%) | ||||||
| CONFUSIONAL STATE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 0/14 (0%) | ||||||
| INSOMNIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 5/16 (31.3%) | 1/14 (7.1%) | ||||||
| Renal and urinary disorders | ||||||||||||
| DYSURIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| HYDRONEPHROSIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| MICTURITION URGENCY | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| NOCTURIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| URINARY INCONTINENCE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| Reproductive system and breast disorders | ||||||||||||
| PELVIC PAIN | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| ASTHMA | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| COUGH | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 1/9 (11.1%) | 6/16 (37.5%) | 7/14 (50%) | ||||||
| DRY THROAT | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| DYSPHONIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 0/14 (0%) | ||||||
| DYSPNOEA | 0/5 (0%) | 3/8 (37.5%) | 0/3 (0%) | 2/9 (22.2%) | 1/16 (6.3%) | 4/14 (28.6%) | ||||||
| DYSPNOEA EXERTIONAL | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 1/14 (7.1%) | ||||||
| EPISTAXIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| HICCUPS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| NASAL CONGESTION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| NASAL ULCER | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 0/16 (0%) | 0/14 (0%) | ||||||
| OBLITERATIVE BRONCHIOLITIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| OROPHARYNGEAL PAIN | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 2/16 (12.5%) | 1/14 (7.1%) | ||||||
| PARANASAL SINUS HYPERSECRETION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| PNEUMONITIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| PRODUCTIVE COUGH | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 1/9 (11.1%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| PULMONARY CONGESTION | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| PULMONARY EMBOLISM | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| RALES | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| RESPIRATORY TRACT OEDEMA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| RHINORRHOEA | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 2/14 (14.3%) | ||||||
| SINUS CONGESTION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| UPPER-AIRWAY COUGH SYNDROME | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 0/14 (0%) | ||||||
| WHEEZING | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| ALOPECIA | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 1/9 (11.1%) | 2/16 (12.5%) | 1/14 (7.1%) | ||||||
| DRY SKIN | 0/5 (0%) | 2/8 (25%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| ERYTHEMA | 0/5 (0%) | 2/8 (25%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| HYPERHIDROSIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| INCREASED TENDENCY TO BRUISE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| NIGHT SWEATS | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| ONYCHOCLASIS | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| PETECHIAE | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| PRURITUS | 1/5 (20%) | 2/8 (25%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 1/14 (7.1%) | ||||||
| PRURITUS GENERALISED | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| RASH | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 1/9 (11.1%) | 1/16 (6.3%) | 3/14 (21.4%) | ||||||
| RASH PRURITIC | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| SEBORRHOEIC DERMATITIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| SKIN BURNING SENSATION | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| Vascular disorders | ||||||||||||
| DEEP VEIN THROMBOSIS | 0/5 (0%) | 0/8 (0%) | 1/3 (33.3%) | 0/9 (0%) | 1/16 (6.3%) | 0/14 (0%) | ||||||
| FLUSHING | 0/5 (0%) | 0/8 (0%) | 1/3 (33.3%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| HOT FLUSH | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 2/16 (12.5%) | 0/14 (0%) | ||||||
| HYPERTENSION | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
| HYPOTENSION | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 1/16 (6.3%) | 1/14 (7.1%) | ||||||
| JUGULAR VEIN THROMBOSIS | 0/5 (0%) | 0/8 (0%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 1/14 (7.1%) | ||||||
| PERIPHERAL COLDNESS | 0/5 (0%) | 1/8 (12.5%) | 0/3 (0%) | 0/9 (0%) | 0/16 (0%) | 0/14 (0%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Thorsten Graef |
|---|---|
| Organization | Pharmacyclics |
| Phone | 855-427-8846 |
| pharmacyclics@medcomsol.com |
Responsible Party:
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT00724984
Other Study ID Numbers:
- PCYC-0403
First Posted:
Jul 30, 2008
Last Update Posted:
Apr 7, 2014
Last Verified:
Feb 1, 2014