Trial Outcomes & Findings for Intensity Modulated Radiation Therapy for Prostate Cancer (NCT NCT00214422)
NCT ID: NCT00214422
Last Updated: 2019-07-19
Results Overview
Radiation side effects were assessed by the Radiation Oncology Group (RTOG) Acute/Late Toxicity Grading Gastrointestinal and Genitourinary criteria. Acute Grade 0 - no symptoms, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening, and Grade 5 is death directly related to radiation side effects. Late toxicity is defined as occurring after 90 days.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
19 participants
Primary outcome timeframe
At one week, one month, 2 months, 3 months, 6 months, 9 months, 1 year, 18 months, 2 years, 30 months, and 3 years after radiation therapy
Results posted on
2019-07-19
Participant Flow
6 participants in Arm 1 participated in a feasibility phase prior to the dose escalation phase of the study.
Participant milestones
| Measure |
Arm 1- 5040cGy to the Lymph Nodes
5040 Gray (cGy) to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 2 - 5400cGy to the Lymph Nodes
5400cGy to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 3 - 5900cGy to the Lymph Nodes
5900cGy to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
3
|
4
|
|
Overall Study
COMPLETED
|
7
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm 1- 5040cGy to the Lymph Nodes
5040 Gray (cGy) to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 2 - 5400cGy to the Lymph Nodes
5400cGy to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 3 - 5900cGy to the Lymph Nodes
5900cGy to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
|
Overall Study
Developed esophageal ca
|
1
|
0
|
0
|
|
Overall Study
Pt taken off study
|
1
|
1
|
0
|
|
Overall Study
Disease progression on study
|
1
|
0
|
0
|
|
Overall Study
Unable to make a radiation treatment
|
0
|
0
|
1
|
Baseline Characteristics
Intensity Modulated Radiation Therapy for Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm 1- 5040cGy to the Lymph Nodes
n=12 Participants
5040 Gray (cGy) to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 2 - 5400cGy to the Lymph Nodes
n=3 Participants
5400cGy to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 3 - 5900cGy to the Lymph Nodes
n=4 Participants
5900cGy to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Continuous
|
64.14 years
STANDARD_DEVIATION 7.41 • n=5 Participants
|
59.37 years
STANDARD_DEVIATION 20.36 • n=7 Participants
|
67.68 years
STANDARD_DEVIATION 2.78 • n=5 Participants
|
64.13 years
STANDARD_DEVIATION 9.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Median Prostatic Specific Antigen (PSA) at Diagnosis
|
16.65 ng/ml
n=5 Participants
|
33.4 ng/ml
n=7 Participants
|
8.95 ng/ml
n=5 Participants
|
19.67 ng/ml
n=4 Participants
|
|
Median Gleason Score at Diagnosis
|
8 scores on a scale
n=5 Participants
|
7 scores on a scale
n=7 Participants
|
8 scores on a scale
n=5 Participants
|
7.6 scores on a scale
n=4 Participants
|
PRIMARY outcome
Timeframe: At one week, one month, 2 months, 3 months, 6 months, 9 months, 1 year, 18 months, 2 years, 30 months, and 3 years after radiation therapyPopulation: 6 participants in Arm 1 participated in a feasibility phase prior to the dose escalation phase of the study.
Radiation side effects were assessed by the Radiation Oncology Group (RTOG) Acute/Late Toxicity Grading Gastrointestinal and Genitourinary criteria. Acute Grade 0 - no symptoms, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening, and Grade 5 is death directly related to radiation side effects. Late toxicity is defined as occurring after 90 days.
Outcome measures
| Measure |
Arm 1- 5040cGy to the Lymph Nodes
n=6 Participants
5040 Gray (cGy) to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 2 - 5400cGy to the Lymph Nodes
Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.
|
Arm 3 - 5900cGY to the Lymph Nodes
Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.
|
|---|---|---|---|
|
Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients)
6 months
|
3 Participants
|
—
|
—
|
|
Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients)
9 months
|
4 Participants
|
—
|
—
|
|
Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients)
1 year
|
2 Participants
|
—
|
—
|
|
Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients)
18 months
|
0 Participants
|
—
|
—
|
|
Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients)
2 years
|
3 Participants
|
—
|
—
|
|
Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients)
30 months
|
1 Participants
|
—
|
—
|
|
Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients)
3 years
|
1 Participants
|
—
|
—
|
|
Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients)
Week 1
|
5 Participants
|
—
|
—
|
|
Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients)
1 month
|
3 Participants
|
—
|
—
|
|
Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients)
2 months
|
4 Participants
|
—
|
—
|
|
Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients)
3 months
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Completion of Treatment, an average of 8.5 weeksPopulation: The MTD of this study was not reached. The original principal investigator left the National Institutes of Health and we are unable to determine why the outcome was not met.
Maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 or more in a cohort of either 3 or 6 patients experiences a dose limiting toxicity (DLT) attributed to radiation therapy. An acute DLT will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At median follow-up, approximately 28 months following radiationLong-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Lower GI/Pelvis grade 2 toxicity Diarrhea requiring parasympatholytic drugs (e.g. Lomotil)/mucous discharge not necessitating sanitary pads/rectal or abdominal pain requiring analgesics and Genitourinary grade 2 defined as Frequency of urination or nocturia that is less frequent than every hour. Dysuria, urgency, bladder spasm requiring local anesthetic (e.g. Pyridium).
Outcome measures
| Measure |
Arm 1- 5040cGy to the Lymph Nodes
n=12 Participants
5040 Gray (cGy) to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 2 - 5400cGy to the Lymph Nodes
n=3 Participants
Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.
|
Arm 3 - 5900cGY to the Lymph Nodes
n=4 Participants
Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.
|
|---|---|---|---|
|
Number of Participants With Grade 2 Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria
Gastrointestinal
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 2 Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria
Genitourinary
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 3 months after completion of radiationAn acute Dose Limiting Toxicity (DLT) will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation.
Outcome measures
| Measure |
Arm 1- 5040cGy to the Lymph Nodes
n=12 Participants
5040 Gray (cGy) to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 2 - 5400cGy to the Lymph Nodes
n=3 Participants
Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.
|
Arm 3 - 5900cGY to the Lymph Nodes
n=4 Participants
Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.
|
|---|---|---|---|
|
Number of Participants With a Dose Limiting Toxicity (DLT)
Gastrointestinal
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Dose Limiting Toxicity (DLT)
Genitourinary
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 8 years and 3.5 months.Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Arm 1- 5040cGy to the Lymph Nodes
n=12 Participants
5040 Gray (cGy) to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 2 - 5400cGy to the Lymph Nodes
n=3 Participants
Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.
|
Arm 3 - 5900cGY to the Lymph Nodes
n=4 Participants
Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.
|
|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
|
12 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At median follow-up, approximately 28 months following radiationLong-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Grade 3 toxicity Lower GI/Pelvis is Diarrhea requiring parenteral support/severe mucous or blood discharge necessitating sanitary pads/abdominal distention (flat plate radiograph demonstrates distended bowel loops), Grade 3 toxicity Genitourinary Frequency with urgency and nocturia hourly or more frequently/dysuria, pelvis pain or bladder spasm requiring regular, frequent narcotic/gross hematuria with/without clot passage.
Outcome measures
| Measure |
Arm 1- 5040cGy to the Lymph Nodes
n=12 Participants
5040 Gray (cGy) to the lymph nodes
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 2 - 5400cGy to the Lymph Nodes
n=3 Participants
Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.
|
Arm 3 - 5900cGY to the Lymph Nodes
n=4 Participants
Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.
|
|---|---|---|---|
|
Number of Participants With Grade 3 or 4 Acute and/or Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria
Gastrointestinal
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Acute and/or Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria
Genitourinary
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Arm 1- 5040cGy to the Lymph Nodes
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm 2 - 5400cGy to the Lymph Nodes
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 3 - 5900cGy to the Lymph Nodes
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1- 5040cGy to the Lymph Nodes
n=12 participants at risk
5040 Gray (cGy) to the lymph nodes
External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 2 - 5400cGy to the Lymph Nodes
n=3 participants at risk
5400cGy to the lymph nodes
External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 3 - 5900cGy to the Lymph Nodes
n=4 participants at risk
5900cGy to the lymph nodes
External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Liver
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
Other adverse events
| Measure |
Arm 1- 5040cGy to the Lymph Nodes
n=12 participants at risk
5040 Gray (cGy) to the lymph nodes
External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 2 - 5400cGy to the Lymph Nodes
n=3 participants at risk
5400cGy to the lymph nodes
External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Arm 3 - 5900cGy to the Lymph Nodes
n=4 participants at risk
5900cGy to the lymph nodes
External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal - Other (Diarrhea)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Diarrhea, mucous discharge, abdo pain)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Renal and urinary disorders
Cystitis
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Penis mass)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
3/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
66.7%
8/12 • Number of events 8 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
83.3%
10/12 • Number of events 16 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Anal lesion - HPV virus (Bx on 1/28/18))
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Esophageal cancer)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Urgency, abdominal pain)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (dysuria)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (frequency)
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (increased bowel frequency)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (loose stools; frequency)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (mild BRBPR (hemorrhoids stable))
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (moderate diarrhea)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (moderate diarrhea, frequency, mucous)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (moderate frequency, urgency)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (rectal bleeding; urgency, frequent watery stools)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Reproductive system and breast disorders
Gynecomastia
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
25.0%
3/12 • Number of events 5 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Rectum
|
25.0%
3/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Renal and urinary disorders
Hemorrhage, GU::Urinary NOS
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Endocrine disorders
Hot flashes/flushes
|
75.0%
9/12 • Number of events 20 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
100.0%
3/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Cardiac disorders
Hypertension
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Cardiac disorders
Hypotension
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Incontinence, anal
|
50.0%
6/12 • Number of events 9 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Renal and urinary disorders
Incontinence, urinary
|
33.3%
4/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
General disorders
Insomnia
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Reproductive system and breast disorders
Libido
|
33.3%
4/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
4/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
100.0%
4/4 • Number of events 12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Nervous system disorders
Mood alteration::Depression
|
25.0%
3/12 • Number of events 7 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Reproductive system and breast disorders
Orgasmic dysfunction
|
50.0%
6/12 • Number of events 6 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Musculoskeletal and connective tissue disorders
Pain - Other (L shoulder)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Musculoskeletal and connective tissue disorders
Pain - Other (R hip)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Musculoskeletal and connective tissue disorders
Pain - Other (Thoracic back pain)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
33.3%
4/12 • Number of events 6 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
75.0%
3/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Reproductive system and breast disorders
Pain::Breast
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Reproductive system and breast disorders
Pain::Pelvis
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Blood and lymphatic system disorders
Platelets
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Dribbling)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Dysuria)
|
33.3%
4/12 • Number of events 5 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
75.0%
3/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
66.7%
8/12 • Number of events 10 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
General disorders
Weight gain
|
83.3%
10/12 • Number of events 17 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
General disorders
Weight loss
|
50.0%
6/12 • Number of events 8 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Cardiac disorders
Cardiac General - Other (heart murmur)
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Blood and lymphatic system disorders
Edema: limb
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Endocrine disorders
Endocrine - Other (breast tenderness)
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Incontinence)
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (blood streaked stool)
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (loose stool, urgency)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (loose stools)
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (small amount blood in stools)
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (urgency)
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Proctitis
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Dysuria, Hematuria)
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (nocturia)
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
General disorders
Edema: limb
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Endocrine disorders
Endocrine - Other (® thyroid size increased)
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (frequency, soft BM's; mild abdo cramping)
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
41.7%
5/12 • Number of events 5 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Renal and urinary disorders
Hemorrhage, GU::Urethra
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Weak stream)
|
50.0%
6/12 • Number of events 10 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
100.0%
3/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (dysuria, nocturia)
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
|
Nervous system disorders
dizziness
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place