Trial Outcomes & Findings for Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma (NCT NCT03426891)

NCT ID: NCT03426891

Last Updated: 2025-10-06

Results Overview

The maximum tolerated dose (MTD)/recommended dose expansion dose of vorinostat given in combination with pembrolizumab, temozolomide, and radiotherapy in patients with newly diagnosed glioblastoma. Toxicities will be graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 for toxicity categories as outlined in the study protocol.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 21 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2025-10-06

Participant Flow

Participant milestones

Measure	Level -1 Level -1: Vorinostat 100 mg/day PO during RTX; 300 mg/day PO after RTX	Level 1 Level 1: Vorinostat 200 mg/day PO during RTX; 300 mg/day PO after RTX	Radiotherapy and Maintenance Phase 100 mg/day Vorinostat (+200 mg Pembro) with radiotherapy and 400 mg/day Vorinostat (+200 mg Pembro) maintenance.
Overall Study STARTED	6	8	7
Overall Study COMPLETED	6	8	6
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma

Baseline characteristics by cohort

Measure	Level -1 n=6 Participants Level -1: Vorinostat 100 mg/day PO during RTX; 300 mg/day PO after RTX	Level 1 n=8 Participants Level 1: Vorinostat 200 mg/day PO during RTX; 300 mg/day PO after RTX	Radiotherapy and Maintenance Phase n=7 Participants 100 mg/day Vorinostat (+200 mg Pembro) with radiotherapy and 400 mg/day Vorinostat (+200 mg Pembro) maintenance.	Total n=21 Participants Total of all reporting groups
Age, Continuous	56.33 years n=5 Participants	60.38 years n=7 Participants	55.57 years n=5 Participants	57.62 years n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 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	1 Participants n=5 Participants	2 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	17 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	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	6 participants n=5 Participants	8 participants n=7 Participants	7 participants n=5 Participants	21 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

The maximum tolerated dose (MTD)/recommended dose expansion dose of vorinostat given in combination with pembrolizumab, temozolomide, and radiotherapy in patients with newly diagnosed glioblastoma. Toxicities will be graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 for toxicity categories as outlined in the study protocol.

Outcome measures

Measure	Dose Escalation Phase n=14 Participants Level -1: Vorinostat 100 mg/day PO during RTX; 300 mg/day PO after RTX Level 1: Vorinostat 200 mg/day PO during RTX; 300 mg/day PO after RTX	Level 1 Level 1: Vorinostat 200 mg/day PO during RTX; 300 mg/day PO after RTX.	Radiotherapy and Maintenance Phase 100 mg/day Vorinostat (+200 mg Pembro) with radiotherapy and 400 mg/day Vorinostat (+200 mg Pembro) maintenance.
Maximum Tolerated Dose (MTD) MTD during RTX	100 mg/day Vorinostat	—	—
Maximum Tolerated Dose (MTD) MTD after RTX	300 mg/day Vorinostat	—	—

SECONDARY outcome

Timeframe: Up to 24 months

Median overall survival rate, 95% confidence survival. OS: Time from randomization until death from any cause.

Outcome measures

Measure	Dose Escalation Phase n=6 Participants Level -1: Vorinostat 100 mg/day PO during RTX; 300 mg/day PO after RTX Level 1: Vorinostat 200 mg/day PO during RTX; 300 mg/day PO after RTX	Level 1 n=8 Participants Level 1: Vorinostat 200 mg/day PO during RTX; 300 mg/day PO after RTX.	Radiotherapy and Maintenance Phase n=7 Participants 100 mg/day Vorinostat (+200 mg Pembro) with radiotherapy and 400 mg/day Vorinostat (+200 mg Pembro) maintenance.
Overall Survival (OS)	NA Months Interval 17.9 to Follow-up period is too short to estimate	12.2 Months Interval 10.7 to Follow-up period is too short to estimate	NA Months Interval 16.2 to Follow-up period is too short to estimate

Adverse Events

Level -1

Serious events: 2 serious events

Other events: 6 other events

Deaths: 3 deaths

Level 1

Serious events: 6 serious events

Other events: 8 other events

Deaths: 5 deaths

Radiotherapy and Maintenance Phase

Serious events: 3 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Measure	Level -1 n=6 participants at risk Level -1: Vorinostat 100 mg/day PO during RTX; 300 mg/day PO after RTX.	Level 1 n=8 participants at risk Level 1: Vorinostat 200 mg/day PO during RTX; 300 mg/day PO after RTX.	Radiotherapy and Maintenance Phase n=7 participants at risk 100 mg/day Vorinostat (+200 mg Pembro) with radiotherapy and 400 mg/day Vorinostat (+200 mg Pembro) maintenance.
Cardiac disorders Myocardial infarction	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Constipation	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Fever	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Flu like symptoms	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Localized edema	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Headache	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Seizure	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Tremor	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Psychiatric disorders Delirium	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Psychiatric disorders Mania	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Skin and subcutaneous tissue disorders Rash maculo-papular	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Surgical and medical procedures Surgical and medical procedures - Other, specify	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Infections and infestations Urinary tract infection	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations Alanine aminotransferase increased	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Renal and urinary disorders Urinary retention	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Vascular disorders Hypotension	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Vascular disorders Thromboembolic event	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Nausea	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Vomiting	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Non-cardiac chest pain	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Pain	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.

Other adverse events

Measure	Level -1 n=6 participants at risk Level -1: Vorinostat 100 mg/day PO during RTX; 300 mg/day PO after RTX.	Level 1 n=8 participants at risk Level 1: Vorinostat 200 mg/day PO during RTX; 300 mg/day PO after RTX.	Radiotherapy and Maintenance Phase n=7 participants at risk 100 mg/day Vorinostat (+200 mg Pembro) with radiotherapy and 400 mg/day Vorinostat (+200 mg Pembro) maintenance.
Investigations Lymphocyte count decreased	100.0% 6/6 • Number of events 31 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	75.0% 6/8 • Number of events 17 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	85.7% 6/7 • Number of events 42 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations Platelet count decreased	100.0% 6/6 • Number of events 17 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	75.0% 6/8 • Number of events 15 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	85.7% 6/7 • Number of events 18 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations Investigations - Other, specify	83.3% 5/6 • Number of events 18 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	100.0% 7/7 • Number of events 20 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations White blood cell decreased	50.0% 3/6 • Number of events 5 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	37.5% 3/8 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	57.1% 4/7 • Number of events 17 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations Alanine aminotransferase increased	50.0% 3/6 • Number of events 12 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	50.0% 4/8 • Number of events 14 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations Aspartate aminotransferase increased	50.0% 3/6 • Number of events 6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	50.0% 4/8 • Number of events 7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 5 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations Creatinine increased	33.3% 2/6 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	57.1% 4/7 • Number of events 6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations Neutrophil count decreased	33.3% 2/6 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations Weight loss	16.7% 1/6 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations Alkaline phosphatase increased	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations Lipase increased	16.7% 1/6 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations Weight gain	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations Blood bilirubin increased	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Investigations Serum amylase increased	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Fatigue	83.3% 5/6 • Number of events 8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	62.5% 5/8 • Number of events 6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	57.1% 4/7 • Number of events 5 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Fever	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	42.9% 3/7 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Localized edema	33.3% 2/6 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Chills	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Edema limbs	33.3% 2/6 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Irritability	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Edema face	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Facial pain	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Flu like symptoms	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Gait disturbance	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Infusion related reaction	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
General disorders Non-cardiac chest pain	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Anorexia	50.0% 3/6 • Number of events 5 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Hyperkalemia	33.3% 2/6 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Hypermagnesemia	50.0% 3/6 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	42.9% 3/7 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Hypokalemia	33.3% 2/6 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	37.5% 3/8 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Hypocalcemia	33.3% 2/6 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Hyponatremia	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	37.5% 3/8 • Number of events 5 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 5 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Hypercalcemia	33.3% 2/6 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Hyperglycemia	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	42.9% 3/7 • Number of events 12 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 2/6 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Hypoglycemia	16.7% 1/6 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Hypernatremia	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Blood and lymphatic system disorders Anemia	83.3% 5/6 • Number of events 9 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	50.0% 4/8 • Number of events 8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	85.7% 6/7 • Number of events 14 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Blood and lymphatic system disorders Leukocytosis	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Headache	50.0% 3/6 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	37.5% 3/8 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Dysphasia	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	37.5% 3/8 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Dizziness	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	42.9% 3/7 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Dysgeusia	50.0% 3/6 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Paresthesia	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Seizure	16.7% 1/6 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Tremor	33.3% 2/6 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Peripheral motor neuropathy	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Ataxia	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Edema cerebral	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Memory impairment	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Peripheral sensory neuropathy	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Nervous system disorders Sinus pain	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Nausea	83.3% 5/6 • Number of events 8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	57.1% 4/7 • Number of events 7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Vomiting	83.3% 5/6 • Number of events 9 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	42.9% 3/7 • Number of events 6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Diarrhea	66.7% 4/6 • Number of events 8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Abdominal distension	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Colitis	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Constipation	33.3% 2/6 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Fecal incontinence	33.3% 2/6 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Mucositis oral	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Bloating	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Dry mouth	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Dyspepsia	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Gastrointestinal disorders Pancreatitis	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Skin and subcutaneous tissue disorders Rash maculo-papular	50.0% 3/6 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Skin and subcutaneous tissue disorders Alopecia	50.0% 3/6 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Skin and subcutaneous tissue disorders Pruritus	50.0% 3/6 • Number of events 5 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	16.7% 1/6 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Skin and subcutaneous tissue disorders Dry skin	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Skin and subcutaneous tissue disorders Hyperhidrosis	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Skin and subcutaneous tissue disorders Bullous dermatitis	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Skin and subcutaneous tissue disorders Rash acneiform	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Skin and subcutaneous tissue disorders Scalp pain	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	33.3% 2/6 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Bone pain	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Musculoskeletal and connective tissue disorders Neck pain	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Psychiatric disorders Insomnia	33.3% 2/6 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	37.5% 3/8 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Psychiatric disorders Depression	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	37.5% 3/8 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Psychiatric disorders Anxiety	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Psychiatric disorders Confusion	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Psychiatric disorders Psychiatric disorders - Other, specify	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Psychiatric disorders Delirium	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Psychiatric disorders Delusions	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Psychiatric disorders Mania	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Psychiatric disorders Psychosis	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Vascular disorders Hypertension	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	50.0% 4/8 • Number of events 4 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Vascular disorders Hypotension	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Vascular disorders Thromboembolic event	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Renal and urinary disorders Hematuria	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Renal and urinary disorders Urinary frequency	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Renal and urinary disorders Chronic kidney disease	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Renal and urinary disorders Urinary retention	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Cardiac disorders Sinus bradycardia	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	28.6% 2/7 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Cardiac disorders Sinus tachycardia	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Cardiac disorders Myocardial infarction	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Infections and infestations Urinary tract infection	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Infections and infestations Lung infection	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Infections and infestations Pharyngitis	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Infections and infestations Sepsis	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Infections and infestations Upper respiratory infection	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Infections and infestations Vaginal infection	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Respiratory, thoracic and mediastinal disorders Atelectasis	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Injury, poisoning and procedural complications Fall	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Injury, poisoning and procedural complications Bruising	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Injury, poisoning and procedural complications Fracture	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Ear and labyrinth disorders Ear pain	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Ear and labyrinth disorders Hearing impaired	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Ear and labyrinth disorders Tinnitus	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	14.3% 1/7 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Endocrine disorders Hypothyroidism	33.3% 2/6 • Number of events 3 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Endocrine disorders Hyperthyroidism	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Eye disorders Eye disorders - Other, specify	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Eye disorders Flashing lights	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	12.5% 1/8 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Eye disorders Floaters	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Surgical and medical procedures Surgical and medical procedures - Other, specify	0.00% 0/6 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	25.0% 2/8 • Number of events 2 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Immune system disorders Immune system disorders - Other, specify	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.
Reproductive system and breast disorders Vaginal inflammation	16.7% 1/6 • Number of events 1 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/8 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.	0.00% 0/7 • 2 years Adverse events were collected in aggregate at each dose level and were not captured per intervention.

Additional Information

Dr. Peter Forsyth

Moffitt Cancer Center

Phone: 813-745-3063

Email: Peter.Forsyth@moffitt.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place