Trial Outcomes & Findings for Ipilimumab and Nivolumab in Leptomeningeal Metastases (NCT NCT02939300)
NCT ID: NCT02939300
Last Updated: 2025-11-14
Results Overview
Overall Survival (OS) is defined as the time from registration to death due to any cause, or censored at date last known alive.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
3 months
Results posted on
2025-11-14
Participant Flow
Participant milestones
| Measure |
Combination Of Nivolumab with Ipilimumab
All patients will be treated based on their primary tumor diagnosis with a combination regimen of Nivolumab and Ipilimumab. Each treatment cycle is 6 weeks; exceptions below.
* Melanoma:
* Nivolumab 1 mg/kg and Ipilimumab 3 mg/kg, every 3 weeks for 4 doses.
* Followed by Nivolumab 480 mg every 4 weeks until disease progression. Each cycle of monotherapy is defined as 8 weeks.
* Non-small Cell Lung Cancer / Head and Neck Cancer:
\- Nivolumab 3 mg/kg every 2 weeks, and Ipilimumab 1 mg/kg every 6 weeks.
* Small Cell Lung Cancer / Breast Cancer / Bladder Cancer:
* Nivolumab 1 mg/kg and Ipilimumab 3 mg/kg, every 3 weeks for 4 doses.
* Followed by Nivolumab 240 mg every 2 weeks until disease progression.
* Renal Cell Carcinoma / Other Solid Tumors (not listed above):
* Nivolumab 3 mg/kg and Ipilimumab 3 mg/kg, every 3 weeks for 4 doses.
* Followed by Nivolumab 480 mg every 4 weeks until disease progression. Each cycle of monotherapy is defined as 8 weeks.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ipilimumab and Nivolumab in Leptomeningeal Metastases
Baseline characteristics by cohort
| Measure |
Combination Of Nivolumab With Ipilimumab
n=18 Participants
All patients will be treated with the combination regimen of Nivolumab at pre-determine dose with Ipilimumab at a pre-determine dose.This will be followed by Nivolumab Monotherapy.
Each treatment Cycle will last 6 weeks
Nivolumab
Ipilimumab
|
|---|---|
|
Age, Continuous
|
54 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=10 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0 = Fully active; no performance restrictions
|
4 Participants
n=10 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1 = Strenuous physical activity restricted; fully ambulatory and able to carry out light work
|
10 Participants
n=10 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
2 = Capable of all self-care but unable to carry out work activities.Up and about >50% of waking hrs
|
4 Participants
n=10 Participants
|
|
Primary tumor diagnosis
Breast Cancer
|
8 Participants
n=10 Participants
|
|
Primary tumor diagnosis
Melanoma
|
2 Participants
n=10 Participants
|
|
Primary tumor diagnosis
Anaplastic astrocytoma
|
1 Participants
n=10 Participants
|
|
Primary tumor diagnosis
Esophageal adenocarcinoma
|
1 Participants
n=10 Participants
|
|
Primary tumor diagnosis
Ependymoma
|
1 Participants
n=10 Participants
|
|
Primary tumor diagnosis
Gastroesophageal (GE) junction adenocarcinoma
|
1 Participants
n=10 Participants
|
|
Primary tumor diagnosis
Glioblastoma
|
1 Participants
n=10 Participants
|
|
Primary tumor diagnosis
Lung adenocarcinoma
|
1 Participants
n=10 Participants
|
|
Primary tumor diagnosis
Ovarian
|
1 Participants
n=10 Participants
|
|
Primary tumor diagnosis
Small cell lung carcinoma
|
1 Participants
n=10 Participants
|
|
Brain metastases at the time of leptomeningeal disease (LMD) diagnosis
Yes
|
13 Participants
n=10 Participants
|
|
Brain metastases at the time of leptomeningeal disease (LMD) diagnosis
No
|
5 Participants
n=10 Participants
|
|
Extracranial disease at the time of leptomeningeal disease (LMD) diagnosis
Yes
|
11 Participants
n=10 Participants
|
|
Extracranial disease at the time of leptomeningeal disease (LMD) diagnosis
No
|
5 Participants
n=10 Participants
|
|
Extracranial disease at the time of leptomeningeal disease (LMD) diagnosis
Unknown
|
2 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 3 monthsOverall Survival (OS) is defined as the time from registration to death due to any cause, or censored at date last known alive.
Outcome measures
| Measure |
Combination Of Nivolumab with Ipilimumab
n=18 Participants
All patients will be treated with the combination regimen of Nivolumab at pre-determine dose with Ipilimumab at a pre-determine dose.This will be followed by Nivolumab Monotherapy.
Each treatment Cycle will last 6 weeks
Nivolumab
Ipilimumab
|
|---|---|
|
Percentage of Participants With Overall Survival
|
44 percentage of participants
Interval 24.0 to 66.0
|
SECONDARY outcome
Timeframe: 2 yearsGrade 3 or 4 treatment-related adverse events occurring in at least 15% of participants, based on CTCAE v4.0 criteria.
Outcome measures
| Measure |
Combination Of Nivolumab with Ipilimumab
n=18 Participants
All patients will be treated with the combination regimen of Nivolumab at pre-determine dose with Ipilimumab at a pre-determine dose.This will be followed by Nivolumab Monotherapy.
Each treatment Cycle will last 6 weeks
Nivolumab
Ipilimumab
|
|---|---|
|
Percentage of Participants With Treatment-related Adverse Events
|
33 percentage of participants
Interval 16.0 to 55.0
|
SECONDARY outcome
Timeframe: 3 months post-treatmentCumulative incidence describes the average probability of developing progressive disease (PD) by immunotherapy response assessment for neuro-oncology (iRANO) criteria. PD is defined as any of the following: (1) \>/= 25% increase in 2-dimensional contrast lesions; (2) significant worsened changes on T2-weighted MRI scans; (3) new lesion; or (4) significant clinical decline. Confirmation of progressive disease is based on follow-up imaging for participants without significant clinical decline.
Outcome measures
| Measure |
Combination Of Nivolumab with Ipilimumab
n=18 Participants
All patients will be treated with the combination regimen of Nivolumab at pre-determine dose with Ipilimumab at a pre-determine dose.This will be followed by Nivolumab Monotherapy.
Each treatment Cycle will last 6 weeks
Nivolumab
Ipilimumab
|
|---|---|
|
Cumulative Incidence of Progressive Disease at 3 Months for Intracranial Sites
|
45 percentage of participants
Interval 25.0 to 80.0
|
SECONDARY outcome
Timeframe: 3 months post-treatmentCumulative incidence describes the average probability of developing progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. PD is defined as any of the following: (1) \>/= 25% increase in 2-dimensional contrast lesions; (2) significant worsened changes on T2-weighted MRI scans; (3) new lesion; or (4) significant clinical decline. Confirmation of progressive disease is based on follow-up imaging for participants without significant clinical decline.
Outcome measures
| Measure |
Combination Of Nivolumab with Ipilimumab
n=18 Participants
All patients will be treated with the combination regimen of Nivolumab at pre-determine dose with Ipilimumab at a pre-determine dose.This will be followed by Nivolumab Monotherapy.
Each treatment Cycle will last 6 weeks
Nivolumab
Ipilimumab
|
|---|---|
|
Cumulative Incidence of Progressive Disease at 3 Months for Extracranial Sites
|
33 percentage of participants
Interval 8.0 to 62.0
|
SECONDARY outcome
Timeframe: 6-9 weeks after treatment initiationPopulation: Due to the clinical nature of LMD with rapidly progressive disease, the majority participants did not undergo post-treatment lumbar punctures before going off study or passing away. CSF cytology 6-9 weeks after treatment initiation was only obtained on 4 participants, which does not provide statistically meaningful interpretation of data. Individual results are reported below.
Cerebrospinal fluid (CSF) collection and cytology is done 6-9 weeks after treatment initiation to assess for LMD response, especially complete response or partial response. Complete Response is defined as: * Reversion to negative CSF cytology (or NA) * Disappearance of all disease related symptoms present prior to therapy (or NA) * Complete disappearance of all detectable radiographic evidence of disease (or NA). Partial Response is defined as: * \> 50% decrease in malignant CSF cytology * Improvement in neurologic symptoms or no worsening of symptoms * Improvement in radiographic evidence of disease. No new sites of measurable or assessable central nervous system (CNS) disease.
Outcome measures
| Measure |
Combination Of Nivolumab with Ipilimumab
n=4 Participants
All patients will be treated with the combination regimen of Nivolumab at pre-determine dose with Ipilimumab at a pre-determine dose.This will be followed by Nivolumab Monotherapy.
Each treatment Cycle will last 6 weeks
Nivolumab
Ipilimumab
|
|---|---|
|
Number of Participants With Leptomeningeal Disease (LMD) Response Post-Treatment
Partial Response
|
1 participants
|
|
Number of Participants With Leptomeningeal Disease (LMD) Response Post-Treatment
Complete Response
|
0 participants
|
SECONDARY outcome
Timeframe: 2 yearsExtracranial Progression-Free Survival (EPFS) is defined as the time from first dose of study drug to documented extracranial disease progression or death, whichever occurs first. Extracranial disease progression is assessed with CT scans of the chest, abdomen, and pelvis, by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria and immune-related response criteria (irRC) criteria. Progression is defined using RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The follow-up of participants who have neither died nor progressed at the time of analysis will be censored at the date of last adequate disease assessment.
Outcome measures
| Measure |
Combination Of Nivolumab with Ipilimumab
n=18 Participants
All patients will be treated with the combination regimen of Nivolumab at pre-determine dose with Ipilimumab at a pre-determine dose.This will be followed by Nivolumab Monotherapy.
Each treatment Cycle will last 6 weeks
Nivolumab
Ipilimumab
|
|---|---|
|
Extracranial Progression-Free Survival
|
1.94 months
Interval 1.35 to 4.44
|
SECONDARY outcome
Timeframe: 2 yearsIntracranial Progression-Free Survival (IPFS) is defined as the time from first dose of study drug to documented intracranial disease progression or death, whichever occurs first. Intracranial disease progression is assessed with CT or MRI scans of the brain, using the Response assessment in neuro-oncology (RANO) criteria, which defines progression as: * ≥ 25% increase in in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline; or * Presence of new lesions; or * Worsening of clinical/neurologic status (unless clearly unrelated to the cancer); or * Worsening of non-measurable disease. The follow-up of participants who have neither died nor progressed at the time of analysis will be censored at the date of last adequate disease assessment.
Outcome measures
| Measure |
Combination Of Nivolumab with Ipilimumab
n=18 Participants
All patients will be treated with the combination regimen of Nivolumab at pre-determine dose with Ipilimumab at a pre-determine dose.This will be followed by Nivolumab Monotherapy.
Each treatment Cycle will last 6 weeks
Nivolumab
Ipilimumab
|
|---|---|
|
Intracranial Progression-Free Survival
|
1.93 months
Interval 1.28 to 2.66
|
Adverse Events
Combination Of Nivolumab with Ipilimumab
Serious events: 10 serious events
Other events: 17 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Combination Of Nivolumab with Ipilimumab
n=18 participants at risk
All patients will be treated with the combination regimen of Nivolumab at pre-determine dose with Ipilimumab at a pre-determine dose.This will be followed by Nivolumab Monotherapy.
Each treatment Cycle will last 6 weeks
Nivolumab
Ipilimumab
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
1/18 • Number of events 2 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Gastrointestinal disorders
Colitis
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Encephalopathy
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
General disorders
Fatigue
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Hydrocephalus
|
16.7%
3/18 • Number of events 3 • 2.5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
5.6%
1/18 • Number of events 2 • 2.5 years
|
|
Nervous system disorders
Meningismus
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Sepsis
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Somnolence
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Renal and urinary disorders
Urinary retention
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Renal and urinary disorders
Urine discoloration
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
General disorders
Death NOS
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
General disorders
General disorders and administration site conditions
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
Other adverse events
| Measure |
Combination Of Nivolumab with Ipilimumab
n=18 participants at risk
All patients will be treated with the combination regimen of Nivolumab at pre-determine dose with Ipilimumab at a pre-determine dose.This will be followed by Nivolumab Monotherapy.
Each treatment Cycle will last 6 weeks
Nivolumab
Ipilimumab
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.8%
5/18 • Number of events 5 • 2.5 years
|
|
Eye disorders
Blurred vision
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
General disorders
Chills
|
5.6%
1/18 • Number of events 3 • 2.5 years
|
|
Gastrointestinal disorders
Colitis
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Concentration impairment
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Psychiatric disorders
Confusion
|
22.2%
4/18 • Number of events 4 • 2.5 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
6/18 • Number of events 8 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
3/18 • Number of events 4 • 2.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Psychiatric disorders
Delirium
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
4/18 • Number of events 6 • 2.5 years
|
|
Nervous system disorders
Dizziness
|
27.8%
5/18 • Number of events 6 • 2.5 years
|
|
Eye disorders
Dry eye
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
3/18 • Number of events 3 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Nervous system disorders
Dysesthesia
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Dysgeusia
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
3/18 • Number of events 3 • 2.5 years
|
|
Ear and labyrinth disorders
Ear pain
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
General disorders
Edema limbs
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Facial muscle weakness
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Injury, poisoning and procedural complications
Fall
|
27.8%
5/18 • Number of events 7 • 2.5 years
|
|
General disorders
Fatigue
|
55.6%
10/18 • Number of events 15 • 2.5 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
General disorders
Fever
|
38.9%
7/18 • Number of events 13 • 2.5 years
|
|
General disorders
Gait disturbance
|
38.9%
7/18 • Number of events 12 • 2.5 years
|
|
Gastrointestinal disorders
Gastritis
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
3/18 • Number of events 3 • 2.5 years
|
|
Nervous system disorders
Headache
|
44.4%
8/18 • Number of events 14 • 2.5 years
|
|
Vascular disorders
Hematoma
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.2%
4/18 • Number of events 8 • 2.5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.1%
2/18 • Number of events 4 • 2.5 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Vascular disorders
Hypertension
|
16.7%
3/18 • Number of events 3 • 2.5 years
|
|
Endocrine disorders
Hyperthyroidism
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
3/18 • Number of events 4 • 2.5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Vascular disorders
Hypotension
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Endocrine disorders
Hypothyroidism
|
5.6%
1/18 • Number of events 2 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
General disorders
Infusion related reaction
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Investigations
INR increased
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Psychiatric disorders
Insomnia
|
16.7%
3/18 • Number of events 4 • 2.5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Investigations
Lipase increased
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Investigations
Lymphocyte count decreased
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Memory impairment
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Meningismus
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
16.7%
3/18 • Number of events 5 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
3/18 • Number of events 3 • 2.5 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
6/18 • Number of events 9 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
3/18 • Number of events 4 • 2.5 years
|
|
Investigations
Neutrophil count decreased
|
11.1%
2/18 • Number of events 3 • 2.5 years
|
|
General disorders
Non-cardiac chest pain
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Nystagmus
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
General disorders
Pain
|
22.2%
4/18 • Number of events 4 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Investigations
Platelet count decreased
|
5.6%
1/18 • Number of events 2 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.2%
4/18 • Number of events 4 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
6/18 • Number of events 7 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Seizure
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Injury, poisoning and procedural complications
Seroma
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Investigations
Serum amylase increased
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Cardiac disorders
Sinus tachycardia
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Sinusitis
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Nervous system disorders
Somnolence
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Infections and infestations
Upper respiratory infection
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Renal and urinary disorders
Urinary incontinence
|
22.2%
4/18 • Number of events 4 • 2.5 years
|
|
Renal and urinary disorders
Urinary retention
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Renal and urinary disorders
Urinary urgency
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Cardiac disorders
Ventricular tachycardia
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Ear and labyrinth disorders
Vertigo
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
6/18 • Number of events 7 • 2.5 years
|
|
Investigations
Weight gain
|
5.6%
1/18 • Number of events 2 • 2.5 years
|
|
Investigations
Weight loss
|
22.2%
4/18 • Number of events 5 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Investigations
White blood cell decreased
|
11.1%
2/18 • Number of events 4 • 2.5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nervous system disorders - Other, specify
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Investigations
Investigations - Other, specify
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Herpes simplex reactivation
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Hepatitis viral
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Gastrointestinal disorders
lip pain
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Paresthesia
|
16.7%
3/18 • Number of events 3 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
16.7%
3/18 • Number of events 3 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
3/18 • Number of events 3 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
General disorders
Arm Pain
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
3/18 • Number of events 5 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
16.7%
3/18 • Number of events 4 • 2.5 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
2/18 • Number of events 2 • 2.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
27.8%
5/18 • Number of events 10 • 2.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
27.8%
5/18 • Number of events 6 • 2.5 years
|
|
Metabolism and nutrition disorders
Acidosis
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Psychiatric disorders
Agitation
|
5.6%
1/18 • Number of events 1 • 2.5 years
|
|
Investigations
Alanine aminotransferase increased
|
27.8%
5/18 • Number of events 10 • 2.5 years
|
|
Investigations
Alkaline phosphatase increased
|
11.1%
2/18 • Number of events 3 • 2.5 years
|
|
Blood and lymphatic system disorders
Anemia
|
22.2%
4/18 • Number of events 8 • 2.5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
9/18 • Number of events 11 • 2.5 years
|
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