Trial Outcomes & Findings for Phase II Trial of Pembrolizumab in Recurrent or Residual High Grade Meningioma (NCT NCT03279692)

Last Updated: 2026-01-29

Results Overview

Progression-free survival at 6 months is defined as not having disease progression per RANO (response assessment in neuro-oncology) criteria or death from any cause within six months of the first day of treatment with pembrolizumab. Contrast-enhanced cranial magnetic resonance imaging (MRI) was performed every 6 weeks to assess patient response to treatment. Progressive disease is defined per RANO criteria as the appearance of a new lesion, an increase in the size of a patient's existing lesions, or clear clinical worsening (seizures, medication side effects, complications of therapy, cerebrovascular events, infection, etc.)

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

up to 6 months

Results posted on

2026-01-29

Participant Flow

One patient withdrew consent before receiving pembrolizumab and was excluded from efficacy and safety analyses.

Participant milestones

Participant milestones
Measure	Pembrolizumab * Pembrolizumab will be administered every 3 weeks * Pembrolizumab will be administered through IV infusion Pembrolizumab: pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Overall Study STARTED	26
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab * Pembrolizumab will be administered every 3 weeks * Pembrolizumab will be administered through IV infusion Pembrolizumab: pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Phase II Trial of Pembrolizumab in Recurrent or Residual High Grade Meningioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab n=25 Participants * Pembrolizumab will be administered every 3 weeks * Pembrolizumab will be administered through IV infusion Pembrolizumab: pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Age, Continuous	60.9 years STANDARD_DEVIATION 16.5 • n=35 Participants
Sex: Female, Male Female	11 Participants n=35 Participants
Sex: Female, Male Male	14 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants
Race (NIH/OMB) Asian	0 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	3 Participants n=35 Participants
Race (NIH/OMB) White	19 Participants n=35 Participants
Race (NIH/OMB) More than one race	1 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=35 Participants

PRIMARY outcome

Timeframe: up to 6 months

Outcome measures

Outcome measures
Measure	Pembrolizumab n=25 Participants * Pembrolizumab will be administered every 3 weeks * Pembrolizumab will be administered through IV infusion Pembrolizumab: pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Progression-free Survival at 6 Months (PFS6)	48 percent of participants Interval 31.0 to 66.0

SECONDARY outcome

Timeframe: Up to 35 months

OS is defined as the time from protocol registration until death due to any cause. The follow-up of patients who were alive at the time of analysis was censored at the date of last assessment of vital status. 90% confidence intervals for median OS were estimated using log(-log(survival)) methodology.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=25 Participants * Pembrolizumab will be administered every 3 weeks * Pembrolizumab will be administered through IV infusion Pembrolizumab: pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Overall Survival (OS)	20.2 months Interval 14.8 to 25.8

SECONDARY outcome

Timeframe: 3 months

OS benchmarked at 3 months measures the percentage of participants who are still alive at 3 months, after study registration and receiving study therapy.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=25 Participants * Pembrolizumab will be administered every 3 weeks * Pembrolizumab will be administered through IV infusion Pembrolizumab: pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Overall Survival (OS) at 3 Months	92 percentage of participants Interval 77.0 to 97.0

SECONDARY outcome

Timeframe: 6 months

OS benchmarked at 6 months measures the percentage of participants who are still alive at 6 months, after study registration and receiving study therapy.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=25 Participants * Pembrolizumab will be administered every 3 weeks * Pembrolizumab will be administered through IV infusion Pembrolizumab: pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Overall Survival (OS) at 6 Months	84 percent of patients Interval 67.0 to 93.0

SECONDARY outcome

Timeframe: Up to 26 months

All adverse events (AEs) recorded during the trial were summarized for all patients who received one or more doses of pembrolizumab. This outcome measure includes adverse events assessed as at least possibly related to study therapy and grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=25 Participants * Pembrolizumab will be administered every 3 weeks * Pembrolizumab will be administered through IV infusion Pembrolizumab: pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Percentage of Participants With Treatment-related Adverse Events	20 Participants

SECONDARY outcome

Timeframe: Up to 25 months

Intracranial response is defined as complete response (CR), partial response (PR), or stable disease (SD) by RANO (response assessment for neuro-oncology) criteria. Intracranial response was assessed by contrast-enhanced cranial magnetic resonance imaging (MRI) every 6 weeks. CR: complete disappearance of all enhancing measurable and non-measurable disease sustained for 4+ weeks, no new lesions, stable/decreasing corticosteroids, and patient is stable and improved clinically. Participants with non-measurable disease cannot have a CR; the best possible response is SD. PR: greater than or equal to 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for 4+ weeks, no progression of non-measurable disease, no new lesions, stable/decreasing corticosteroids, and patient is stable or improved clinically. SD: does not qualify for CR, PR, or disease progression and patient is stable clinically.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=25 Participants * Pembrolizumab will be administered every 3 weeks * Pembrolizumab will be administered through IV infusion Pembrolizumab: pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Number of Participants With Intracranial Response Complete Response	0 Participants
Number of Participants With Intracranial Response Partial Response	0 Participants
Number of Participants With Intracranial Response Stable Disease	18 Participants

Adverse Events

Pembrolizumab

Serious events: 10 serious events

Other events: 25 other events

Deaths: 15 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab n=25 participants at risk * Pembrolizumab will be administered every 3 weeks * Pembrolizumab will be administered through IV infusion Pembrolizumab: pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Nervous system disorders Headache	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Gastrointestinal disorders Nausea	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Gastrointestinal disorders Vomiting	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Infections and infestations Lung Infection	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Skin and subcutaneous tissue disorders Skin/subcutaneous tissue disorders - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Seizure	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Psychiatric disorders Confusion	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Gastrointestinal disorders Colitis	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Musculoskeletal and connective tissue disorders Generalized Muscle weakness	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Renal and urinary disorders Urinary Incontinence	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Vascular disorders Thromboembolic event	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Infections and infestations Skin infection	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Encephalopathy	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Surgical and medical procedures Surgical and medical procedures - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Blood and lymphatic system disorders Anemia	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Alanine aminotransferase increased	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Alkaline phosphatase increased	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Aspartate Aminotransferase increased	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Dysarthria	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.

Other adverse events

Other adverse events
Measure	Pembrolizumab n=25 participants at risk * Pembrolizumab will be administered every 3 weeks * Pembrolizumab will be administered through IV infusion Pembrolizumab: pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Endocrine disorders Adrenal Insufficiency	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Alanine aminotransferase increased	16.0% 4/25 • Number of events 4 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Alkaline phosphatase increased	16.0% 4/25 • Number of events 4 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Alopecia	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Blood and lymphatic system disorders Anemia	28.0% 7/25 • Number of events 11 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Metabolism and nutrition disorders Anorexia	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Psychiatric disorders Anxiety	12.0% 3/25 • Number of events 3 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Aspartate Aminotransferase Increased	12.0% 3/25 • Number of events 3 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Ataxia	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Musculoskeletal and connective tissue disorders Back Pain	16.0% 4/25 • Number of events 7 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Gastrointestinal disorders Bloating	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Blood bilirubin increased	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Blood corticotrophin decreased	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Cardiac disorders Cardiac disorders - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
General disorders Chills	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Cholesterol High	28.0% 7/25 • Number of events 7 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Cognitive Disturbance	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Gastrointestinal disorders Colitis	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Concentration Impairment	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Psychiatric disorders Confusion	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Eye disorders Conjunctivitis	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Gastrointestinal disorders Constipation	32.0% 8/25 • Number of events 8 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Respiratory, thoracic and mediastinal disorders Cough	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Creatinine Increased	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Metabolism and nutrition disorders Dehydration	12.0% 3/25 • Number of events 3 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Psychiatric disorders Depression	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Gastrointestinal disorders Diarrhea	12.0% 3/25 • Number of events 3 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Dizziness	20.0% 5/25 • Number of events 5 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Skin and subcutaneous tissue disorders Dry skin	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Dysphasia	12.0% 3/25 • Number of events 3 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Ear and labyrinth disorders Ear Pain	8.0% 2/25 • Number of events 3 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Edema cerebral	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
General disorders Edema face	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
General disorders Edema limbs	20.0% 5/25 • Number of events 5 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Infections and infestations Enterocolitis infectious	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Skin and subcutaneous tissue disorders Erythema multiforme	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Gastrointestinal disorders Esophagitis	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Eye disorders Eye disorders - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Eye disorders Eye pain	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Facial muscle weakness	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Injury, poisoning and procedural complications Fall	40.0% 10/25 • Number of events 18 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
General disorders Fatigue	48.0% 12/25 • Number of events 15 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
General disorders Fever	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
General disorders Flu like symptoms	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Injury, poisoning and procedural complications Fracture	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
General disorders Gait disturbance	28.0% 7/25 • Number of events 9 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
General disorders General disorders and administration site conditions - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	24.0% 6/25 • Number of events 7 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Headache	16.0% 4/25 • Number of events 6 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Ear and labyrinth disorders Hearing impaired	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Metabolism and nutrition disorders Hyperglycemia	28.0% 7/25 • Number of events 8 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Metabolism and nutrition disorders Hyperkalemia	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Vascular disorders Hypertension	20.0% 5/25 • Number of events 6 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Endocrine disorders Hyperthyroidism	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Metabolism and nutrition disorders Hyperuricemia	12.0% 3/25 • Number of events 4 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Metabolism and nutrition disorders Hypokalemia	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Metabolism and nutrition disorders Hyponatremia	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Metabolism and nutrition disorders Hypophosphatemia	28.0% 7/25 • Number of events 7 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Vascular disorders Hypotension	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Endocrine disorders Hypothyroidism	8.0% 2/25 • Number of events 4 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Infections and infestations Infections and infestations - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Psychiatric disorders Insomnia	28.0% 7/25 • Number of events 7 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Intracranial hemorrhage	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Investigations - Other, specify	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Infections and infestations Investigations - Other, specify	28.0% 7/25 • Number of events 8 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Lethargy	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Blood and lymphatic system disorders Leukocytosis	16.0% 4/25 • Number of events 5 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Lipase increased	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
General disorders Localized edema	4.0% 1/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Infections and infestations Lung infection	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Lymphocyte count decreased	16.0% 4/25 • Number of events 5 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Memory impairment	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	12.0% 3/25 • Number of events 3 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	8.0% 2/25 • Number of events 3 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Musculoskeletal and connective tissue disorders Myalgia	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Gastrointestinal disorders Nausea	12.0% 3/25 • Number of events 4 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Musculoskeletal and connective tissue disorders Neck edema	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Musculoskeletal and connective tissue disorders Neck pain	12.0% 3/25 • Number of events 3 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Nervous system disorders - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Neutrophil count decreased	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
General disorders Non-cardiac chest pain	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Gastrointestinal disorders Oral pain	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
General disorders Pain	16.0% 4/25 • Number of events 5 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Musculoskeletal and connective tissue disorders Pain in extremity	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Eye disorders Papilledema	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Paresthesia	8.0% 2/25 • Number of events 4 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Peripheral motor neuropathy	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Peripheral sensory neuropathy	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Platelet count decreased	4.0% 1/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Presyncope	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Skin and subcutaneous tissue disorders Pruritus	28.0% 7/25 • Number of events 10 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Psychiatric disorders Psychiatric disorders - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.0% 3/25 • Number of events 3 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Renal and urinary disorders Urinary frequency	16.0% 4/25 • Number of events 6 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Infections and infestations Upper Respiratory Infection	8.0% 2/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Cardiac disorders Restrictive cardiomyopathy	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Gastrointestinal disorders Retroperitoneal hemorrhage	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Skin and subcutaneous tissue disorders Scalp pain	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Seizure	24.0% 6/25 • Number of events 10 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Serum amylase increased	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Cardiac disorders Sinus bradycardia	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Cardiac disorders Sinus tachycardia	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Infections and infestations Sinusitis	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Infections and infestations Skin infection	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Skin and subcutaneous tissue disorders Skin/subcutaneous tissue disorders; Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Skin and subcutaneous tissue disorders Truncal rash	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Somnolence	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Respiratory, thoracic and mediastinal disorders Sore throat	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Spasticity	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Injury, poisoning and procedural complications Spinal fracture	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	4.0% 1/25 • Number of events 2 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Ear and labyrinth disorders Tinnitus	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Nervous system disorders Tremor	12.0% 3/25 • Number of events 3 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Renal and urinary disorders Urinary Incontinence	12.0% 3/25 • Number of events 3 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Infections and infestations Urinary tract infection	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Renal and urinary disorders Urinary urgency	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Reproductive system and breast disorders Vaginal dryness	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Infections and infestations Vaginal infection	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Vascular disorders Vascular disorders - Other, specify	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Ear and labyrinth disorders Vertigo	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Gastrointestinal disorders Vomiting	12.0% 3/25 • Number of events 4 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Weight gain	4.0% 1/25 • Number of events 1 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations Weight loss	8.0% 2/25 • Number of events 3 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.
Investigations White blood cell decreased	12.0% 3/25 • Number of events 5 • up to 3 years In addition to the clinicaltrials.gov seriousness criteria, the following seriousness criteria are added: (1) new cancer (that is not a condition of the study) and (2) associated with an overdose.

Additional Information

Priscilla Brastianos, MD

Massachusetts General Hospital

Phone: 617-724-8770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place