Trial Outcomes & Findings for Study of Bortezomib and Docetaxel for Patients With Hormone Refractory Prostate Cancer (NCT NCT00183937)
NCT ID: NCT00183937
Last Updated: 2026-05-15
Results Overview
Participants should be reevaluated for PSA response every 21 days. A confirmatory PSA level should be obtained 3-4 weeks following initial documentation of a PSA response.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Every end of each cycle (21 days) up to 12 cycles
Results posted on
2026-05-15
Participant Flow
Participant milestones
| Measure |
Bortezomib and Docetaxel
Bortezomib 1.6 mg/m2 Docetaxel 75 mg/m2
PS 341: PS 341 1.6 mg/m2 IV (in the vein) on days 1 and 8 of each 21 day cycle up to 12 cycles.
Docetaxel: Docetaxel 75mg/m2 IV (in the vein) on day 1 of each 21 day cycle up to 12 cycles.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Bortezomib and Docetaxel
Bortezomib 1.6 mg/m2 Docetaxel 75 mg/m2
PS 341: PS 341 1.6 mg/m2 IV (in the vein) on days 1 and 8 of each 21 day cycle up to 12 cycles.
Docetaxel: Docetaxel 75mg/m2 IV (in the vein) on day 1 of each 21 day cycle up to 12 cycles.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
started alternative therapy
|
1
|
Baseline Characteristics
Study of Bortezomib and Docetaxel for Patients With Hormone Refractory Prostate Cancer
Baseline characteristics by cohort
| Measure |
Bortezomib and Docetaxel
n=15 Participants
Bortezomib 1.6 mg/m2 Docetaxel 75 mg/m2
PS 341: PS 341 1.6 mg/m2 IV (in the vein) on days 1 and 8 of each 21 day cycle up to 12 cycles.
Docetaxel: Docetaxel 75mg/m2 IV (in the vein) on day 1 of each 21 day cycle up to 12 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=11 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=11 Participants
|
PRIMARY outcome
Timeframe: Every end of each cycle (21 days) up to 12 cyclesParticipants should be reevaluated for PSA response every 21 days. A confirmatory PSA level should be obtained 3-4 weeks following initial documentation of a PSA response.
Outcome measures
| Measure |
Bortezomib and Docetaxel
n=14 Participants
Bortezomib 1.6 mg/m2 Docetaxel 75 mg/m2
PS 341: PS 341 1.6 mg/m2 IV (in the vein) on days 1 and 8 of each 21 day cycle up to 12 cycles.
Docetaxel: Docetaxel 75mg/m2 IV (in the vein) on day 1 of each 21 day cycle up to 12 cycles.
|
|---|---|
|
PSA Response Rate
|
64 percentage of participants
|
SECONDARY outcome
Timeframe: At baseline, then weekly for 4 weeks up to 36 weeksPopulation: The sponsor, Aventis Pasteur Limited, stopped the study early before it met the study accrual goal. Since the study ended early due to lack of funding. The pre-specified measurement values were not obtained and they will never be collected in the future.
Participants will be considered evaluable for a pain response if the baseline analgesic use was determined, and at least 4 weekly assessments of PPI and analgesic score are available from any 8-week period from the period after the initiation of therapy until discontinuation of study medication.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 4 weeks after the last dose of study drug, up to 3 years.Outcome measures
| Measure |
Bortezomib and Docetaxel
n=15 Participants
Bortezomib 1.6 mg/m2 Docetaxel 75 mg/m2
PS 341: PS 341 1.6 mg/m2 IV (in the vein) on days 1 and 8 of each 21 day cycle up to 12 cycles.
Docetaxel: Docetaxel 75mg/m2 IV (in the vein) on day 1 of each 21 day cycle up to 12 cycles.
|
|---|---|
|
RECIST Response
Partial Response (PR)
|
9 Participants
|
|
RECIST Response
Stable Disease (SD)
|
4 Participants
|
|
RECIST Response
Progressive Disease (PD)
|
1 Participants
|
|
RECIST Response
Inevaluable For Response
|
1 Participants
|
SECONDARY outcome
Timeframe: At 3 weeks after the last dose of study drug, up to 3 years.Each adverse event will be determined by using the NCI CTCAE, version 3.0.
Outcome measures
| Measure |
Bortezomib and Docetaxel
n=15 Participants
Bortezomib 1.6 mg/m2 Docetaxel 75 mg/m2
PS 341: PS 341 1.6 mg/m2 IV (in the vein) on days 1 and 8 of each 21 day cycle up to 12 cycles.
Docetaxel: Docetaxel 75mg/m2 IV (in the vein) on day 1 of each 21 day cycle up to 12 cycles.
|
|---|---|
|
Therapeutic Toxicity Assessment
Patients Experienced Grade 3, 4, or 5 Toxicities
|
10 Participants
|
|
Therapeutic Toxicity Assessment
Patients Experienced Grade 1 or 2 Toxicities Only
|
5 Participants
|
|
Therapeutic Toxicity Assessment
No Treatment Related Toxicity Observed
|
0 Participants
|
|
Therapeutic Toxicity Assessment
No Toxicity Reported
|
0 Participants
|
Adverse Events
Bortezomib and Docetaxel
Serious events: 15 serious events
Other events: 15 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Bortezomib and Docetaxel
n=15 participants at risk
Bortezomib 1.6 mg/m2 Docetaxel 75 mg/m2
PS 341: PS 341 1.6 mg/m2 IV (in the vein) on days 1 and 8 of each 21 day cycle up to 12 cycles.
Docetaxel: Docetaxel 75mg/m2 IV (in the vein) on day 1 of each 21 day cycle up to 12 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
leukocytes (total WBC)
|
33.3%
5/15 • Number of events 13 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.7%
1/15 • Number of events 11 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
53.3%
8/15 • Number of events 17 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Cardiac disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
General disorders
Constitutional Symptoms - Other
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise
|
33.3%
5/15 • Number of events 8 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
General disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Anorexia
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Infections and infestations
Febrile neutropenia
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
20.0%
3/15 • Number of events 6 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Pain (Abdomen NOS)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain (Back)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain (Bone)
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain (Joint)
|
6.7%
1/15 • Number of events 3 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
Other adverse events
| Measure |
Bortezomib and Docetaxel
n=15 participants at risk
Bortezomib 1.6 mg/m2 Docetaxel 75 mg/m2
PS 341: PS 341 1.6 mg/m2 IV (in the vein) on days 1 and 8 of each 21 day cycle up to 12 cycles.
Docetaxel: Docetaxel 75mg/m2 IV (in the vein) on day 1 of each 21 day cycle up to 12 cycles.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pain (Back)
|
40.0%
6/15 • Number of events 6 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain (Bone)
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain (Extremity-limb)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Nervous system disorders
Pain (Head/headache)
|
20.0%
3/15 • Number of events 3 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain (Joint)
|
33.3%
5/15 • Number of events 5 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain (Muscle)
|
46.7%
7/15 • Number of events 7 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Pain (Stomach)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
20.0%
3/15 • Number of events 3 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
20.0%
3/15 • Number of events 3 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
15/15 • Number of events 15 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
33.3%
5/15 • Number of events 5 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Blood and lymphatic system disorders
Platelets
|
20.0%
3/15 • Number of events 3 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Cardiac disorders
Prolonged QTc interval
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia (Sinus arrhythmia)
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia (Sinus bradycardia)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia (Sinus tachycardia)
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia (Supraventricular tachycardia)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
General disorders
Constitutional Symptoms - Other
|
33.3%
5/15 • Number of events 5 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
66.7%
10/15 • Number of events 10 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
General disorders
Insomnia
|
46.7%
7/15 • Number of events 7 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
General disorders
Weight loss
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
93.3%
14/15 • Number of events 14 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
20.0%
3/15 • Number of events 3 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
33.3%
5/15 • Number of events 5 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
33.3%
5/15 • Number of events 5 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
40.0%
6/15 • Number of events 6 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Anorexia
|
53.3%
8/15 • Number of events 8 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
60.0%
9/15 • Number of events 9 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Dental: teeth
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
53.3%
8/15 • Number of events 8 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) (Oral cavity)
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) (Oral cavity)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
9/15 • Number of events 9 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
73.3%
11/15 • Number of events 11 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
6/15 • Number of events 6 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Renal and urinary disorders
Hemorrhage, GU (Urinary NOS)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Injury, poisoning and procedural complications
Hemorrhage/Bleeding - Other
|
20.0%
3/15 • Number of events 3 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Infections and infestations
Infection - Other
|
20.0%
3/15 • Number of events 3 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Middle ear (otitis media))
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Upper airway NOS)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Infections and infestations
Infection with unknown ANC (Bladder (urinary)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Infections and infestations
Infection with unknown ANC (Dental-tooth)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Blood and lymphatic system disorders
Edema: limb
|
73.3%
11/15 • Number of events 11 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
ALT (SGPT)
|
40.0%
6/15 • Number of events 6 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
AST (SGOT)
|
46.7%
7/15 • Number of events 7 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
33.3%
5/15 • Number of events 5 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
40.0%
6/15 • Number of events 6 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
Creatinine
|
26.7%
4/15 • Number of events 4 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
53.3%
8/15 • Number of events 8 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
53.3%
8/15 • Number of events 8 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis (Extremity-lower)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Ear and labyrinth disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Psychiatric disorders
Mood alteration (Anxiety)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Nervous system disorders
Neuropathy: cranial (CN VIII Hearing and balance)
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Nervous system disorders
Neuropathy: motor
|
26.7%
4/15 • Number of events 4 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Nervous system disorders
Neuropathy: sensory
|
73.3%
11/15 • Number of events 11 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Eye disorders
Cataract
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Eye disorders
Ocular surface disease
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Eye disorders
Ocular/Visual - Other
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Eye disorders
Vision-blurred vision
|
26.7%
4/15 • Number of events 4 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Pain (Abdomen NOS)
|
26.7%
4/15 • Number of events 4 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
6.7%
1/15 • Number of events 1 • At 3 weeks after the last dose of study drug, up to 3 years.
|
|
General disorders
Flu-like syndrome
|
13.3%
2/15 • Number of events 2 • At 3 weeks after the last dose of study drug, up to 3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place