Trial Outcomes & Findings for Lithium for Low-Grade Neuroendocrine Tumors (NCT NCT00501540)

Last Updated: 2019-11-26

Results Overview

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>=20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), small changes that do not meet the above criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Up to 4 years

Results posted on

2019-11-26

Participant Flow

This study enrolled participants with low grade neuroendocrine tumors (NETs) from July 2007 through May 2009.

Participant milestones

Participant milestones
Measure	Lithium Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment. Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.
Overall Study STARTED	15
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Lithium Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment. Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.
Overall Study Death	5

Baseline Characteristics

Lithium for Low-Grade Neuroendocrine Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lithium n=15 Participants Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment. Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 years

Outcome measures

Outcome measures
Measure	Lithium n=15 Participants Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment. Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.
Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) Complete Response (CR)	0 participants
Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) Partial Response (PR)	0 participants
Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) Progressive Disease (PD)	0 participants
Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) Stable Disease (SD)	8 participants

SECONDARY outcome

Timeframe: Up to 4 years

Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival is measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression. If a participant did not experience an event of disease progression or death at the time of analysis (03/10/2011), then the patient's data was censored at the date of the last available evaluation.

Outcome measures

Outcome measures
Measure	Lithium n=15 Participants Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment. Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.
Progression Free Survival (PFS)	4.50 months Interval 2.99 to 4.5

SECONDARY outcome

Timeframe: Up to 4 years

Population: The median OS time had not been reached.

Overall survival for a participant is defined as the number of days from the day of first Lithium administration to the participant's death. As of the time of analysis (03/10/2011), median overall survival duration was not reached.

Outcome measures

Outcome measures
Measure	Lithium n=15 Participants Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment. Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.
Overall Survival (OS)	NA participants 50% of participants had not died at the time that the final statistics were run.

Adverse Events

Lithium

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lithium n=15 participants at risk Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment. Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.
Investigations Creatinine	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Metabolism and nutrition disorders Glucose	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Investigations Hemoglobin	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Gastrointestinal disorders Ileus, GI	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
General disorders Pain	13.3% 2/15 • Number of events 3 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Investigations Sodium	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Gastrointestinal disorders Stricture/stenosis	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.

Other adverse events

Other adverse events
Measure	Lithium n=15 participants at risk Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment. Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.
Gastrointestinal disorders Abdominal pain	60.0% 9/15 • Number of events 14 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Hepatobiliary disorders Acute cholecystitis	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Blood and lymphatic system disorders Anemia	20.0% 3/15 • Number of events 5 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Gastrointestinal disorders Anorexia	40.0% 6/15 • Number of events 7 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Musculoskeletal and connective tissue disorders Back pain	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Psychiatric disorders Cognitive disturbance/confusion	13.3% 2/15 • Number of events 2 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
General disorders Cold	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
General disorders Cold sensation in hands	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Gastrointestinal disorders Constipation	13.3% 2/15 • Number of events 3 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Investigations Creatinine	26.7% 4/15 • Number of events 6 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Metabolism and nutrition disorders Dehydration	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Gastrointestinal disorders Diarrhea	46.7% 7/15 • Number of events 15 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Nervous system disorders Dizziness	13.3% 2/15 • Number of events 2 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
General disorders Edema	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Endocrine disorders Elevated TSH	6.7% 1/15 • Number of events 2 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Blood and lymphatic system disorders Elevated white blood count	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
General disorders Emotional changes	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
General disorders Fatigue	73.3% 11/15 • Number of events 20 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
General disorders Fever	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Vascular disorders Flushing	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Renal and urinary disorders Frequency	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Gastrointestinal disorders Gas pain	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Nervous system disorders Headache	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Gastrointestinal disorders Hemorrhoids	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Investigations High ALT	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Investigations High AST	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Investigations High INR	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Endocrine disorders High Parathyroid Hormone	6.7% 1/15 • Number of events 2 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Vascular disorders Hot flashes	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Investigations Hyperbilirubinemia	6.7% 1/15 • Number of events 8 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Investigations Hypercalcemia	13.3% 2/15 • Number of events 3 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Metabolism and nutrition disorders Hyperglycemia	33.3% 5/15 • Number of events 15 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Endocrine disorders Hyperthyroidism	6.7% 1/15 • Number of events 3 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Metabolism and nutrition disorders Hypocalcemia	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Metabolism and nutrition disorders Hypokalemia	6.7% 1/15 • Number of events 5 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Metabolism and nutrition disorders Hyponatremia	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Metabolism and nutrition disorders Hypophosphatemia	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Gastrointestinal disorders Increased gas	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Psychiatric disorders Insomnia	13.3% 2/15 • Number of events 4 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Vascular disorders Ischemia of small bowel leading to necrosis	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Metabolism and nutrition disorders Low Anion Gap	6.7% 1/15 • Number of events 2 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Renal and urinary disorders Low EGFR	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Investigations Lymphopenia	26.7% 4/15 • Number of events 9 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Nervous system disorders Memory Impairment	13.3% 2/15 • Number of events 2 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Gastrointestinal disorders Nausea	46.7% 7/15 • Number of events 9 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
General disorders Panic Attacks	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Skin and subcutaneous tissue disorders Puritis	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Musculoskeletal and connective tissue disorders Shaky legs	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Respiratory, thoracic and mediastinal disorders Sore throat	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Blood and lymphatic system disorders Stricture of mesenteric artery	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Blood and lymphatic system disorders Thrombocytopenia	26.7% 4/15 • Number of events 9 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Nervous system disorders Tremors	33.3% 5/15 • Number of events 6 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Musculoskeletal and connective tissue disorders Unsteady Gait	6.7% 1/15 • Number of events 1 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
Gastrointestinal disorders Vomiting	26.7% 4/15 • Number of events 6 • Adverse event data were collected on or after Day 0 through 4 years. Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.

Additional Information

Dr. Noelle LoConte

University of Wisconsin Carbone Cancer Center

Phone: 608-265-5883

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place