Trial Outcomes & Findings for Lenalidomide and Doxorubicin Hydrochloride Liposome in Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer (NCT NCT00903630)
NCT ID: NCT00903630
Last Updated: 2017-12-28
Results Overview
The maximum tolerated dose (MTD) reflects the highest dose of Lenalidomide when combined with fixed dose Liposomal Doxorubicin at which no more than one out of 6 participants experiences a dose limiting toxicity (DLT).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
1 cycle (28 days)
Results posted on
2017-12-28
Participant Flow
Fifteen subjects were enrolled in this combined phase l/ll study - 11 subjects in phase l and 4 in phase ll. Six of the subjects enrolled in phase 1 were treated at the maximum tolerated dose (MTD) and their data was included in the phase 2 analysis as allowed by the protocol.
Participant milestones
| Measure |
Phase 1 - Dose Level 1
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
|
Phase 1 - Dose Level 2
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
|
Phase 2 - Dose Level 1
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
|
|---|---|---|---|
|
Phase l
STARTED
|
6
|
5
|
0
|
|
Phase l
COMPLETED
|
6
|
5
|
0
|
|
Phase l
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
6
|
0
|
4
|
|
Phase 2
COMPLETED
|
6
|
0
|
3
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Phase 1 - Dose Level 1
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
|
Phase 1 - Dose Level 2
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
|
Phase 2 - Dose Level 1
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
|
|---|---|---|---|
|
Phase 2
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
Lenalidomide and Doxorubicin Hydrochloride Liposome in Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Phase 1 - Dose Level 1
n=6 Participants
|
Phase 1 - Dose Level 2
n=5 Participants
|
Phase 2
n=4 Participants
|
Total
n=15 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
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
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
15 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 cycle (28 days)The maximum tolerated dose (MTD) reflects the highest dose of Lenalidomide when combined with fixed dose Liposomal Doxorubicin at which no more than one out of 6 participants experiences a dose limiting toxicity (DLT).
Outcome measures
| Measure |
Phase 1 - Dose Level 1
n=11 Participants
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
Phase I - Dose Level 2
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
Phase 2
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
|---|---|---|---|
|
Phase 1 - Maximum Tolerated Dose (MTD) of Lenalidomide When Combined With Fixed Dose Liposomal Doxorubicin in Women With Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
|
10 milligrams (mg)
|
—
|
—
|
PRIMARY outcome
Timeframe: within 5 weeks of starting treatmentDLT is defined as the inability to complete cycle 1 and/or begin cycle 2 within 7 days of the planned start due to a grade 4 or greater hemtologic toxicity or a grade 3 or greater non-hematologic toxicity. Grading was based on Common Toxicity Criteria (CTC) Version 4.
Outcome measures
| Measure |
Phase 1 - Dose Level 1
n=6 Participants
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
Phase I - Dose Level 2
n=5 Participants
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
Phase 2
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
|---|---|---|---|
|
Phase 1 - Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
|
0 participants
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: 3 months after starting treatmentPartial response is defined as: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met. Complete response is defined as: The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.
Outcome measures
| Measure |
Phase 1 - Dose Level 1
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
Phase I - Dose Level 2
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
Phase 2
n=9 Participants
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
|---|---|---|---|
|
Phase 2 - Number of Subjects Achieving a Partial or Complete Response
|
—
|
—
|
1 participants
|
SECONDARY outcome
Timeframe: 3 months after starting treatmentProgression is defined as: At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
Outcome measures
| Measure |
Phase 1 - Dose Level 1
n=9 Participants
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
Phase I - Dose Level 2
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
Phase 2
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
|---|---|---|---|
|
Phase 2 - Number of Subjects Who Are Progression-Free and Alive
|
8 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months after starting treatmentProgression is defined as: At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurement, or the appearance of one or more new lesion(s).
Outcome measures
| Measure |
Phase 1 - Dose Level 1
n=9 Participants
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
Phase I - Dose Level 2
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
Phase 2
liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
|---|---|---|---|
|
Phase 2 - Number of Subjects Who Are Progression-Free and Alive
|
5 participants
|
—
|
—
|
Adverse Events
Phase 1 - Dose Level 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1 - Dose Level 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 - Dose Level 1
n=6 participants at risk
Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.
Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle
pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
Phase 1 - Dose Level 2
n=5 participants at risk
Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.
Lenalidomide: Administered by mouth at the assigned dose of 15 mg daily of each 28 day cycle
pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
Phase 2
n=4 participants at risk
Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.
Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle
pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
|---|---|---|---|
|
General disorders
fever
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
Other adverse events
| Measure |
Phase 1 - Dose Level 1
n=6 participants at risk
Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.
Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle
pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
Phase 1 - Dose Level 2
n=5 participants at risk
Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.
Lenalidomide: Administered by mouth at the assigned dose of 15 mg daily of each 28 day cycle
pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
Phase 2
n=4 participants at risk
Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.
Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle
pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6
|
20.0%
1/5
|
25.0%
1/4
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Eye disorders
Blurred vision
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6
|
0.00%
0/5
|
50.0%
2/4
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6
|
40.0%
2/5
|
25.0%
1/4
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6
|
40.0%
2/5
|
25.0%
1/4
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Gastrointestinal disorders
Mucositis, oral
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6
|
0.00%
0/5
|
75.0%
3/4
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
|
General disorders
Edema, limbs
|
16.7%
1/6
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
Fatigue
|
33.3%
2/6
|
60.0%
3/5
|
50.0%
2/4
|
|
General disorders
Pain NOS
|
0.00%
0/6
|
0.00%
0/5
|
50.0%
2/4
|
|
General disorders
Chills
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
|
Infections and infestations
Bronchial infection
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6
|
20.0%
1/5
|
50.0%
2/4
|
|
Investigations
Platelet count decreased
|
0.00%
0/6
|
20.0%
1/5
|
25.0%
1/4
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6
|
0.00%
0/5
|
50.0%
2/4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps, foot
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
20.0%
1/5
|
25.0%
1/4
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
|
Psychiatric disorders
Depression
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6
|
0.00%
0/5
|
50.0%
2/4
|
|
Renal and urinary disorders
Burning with urination, intermittent
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Renal and urinary disorders
Bladder discomfort NOS
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6
|
20.0%
1/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath with intermittent wheezing
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Plantar palmar erythrodysesthesia syndrome
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
16.7%
1/6
|
20.0%
1/5
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Red spots, hands
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Skin pain
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Infections and infestations
Infection, toe
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
33.3%
2/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Rash, lower extremeities
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Vascular disorders
Hypotension
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
|
Vascular disorders
Phlebitis, arm
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
Additional Information
Dr. Levi Downs, Jr
University of Minnesota, Dept. of OBGYN
Phone: 612-626-3111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place