Trial Outcomes & Findings for Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery (NCT NCT02730546)
NCT ID: NCT02730546
Last Updated: 2025-06-22
Results Overview
Defined as number of patients with pathologic complete responses (pCR) divided by total evaluable patients. pCR is defined as no recognized cancer and margins free of tumor as found by the pathologist following resection of the esophageal specimen and accompanying lymph nodes.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2025-06-22
Participant Flow
Participant milestones
| Measure |
Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery)
See Detailed Description\>
\> Carboplatin: Given IV\>
\> Computed Tomography: Undergo CT scan\>
\> Fluorouracil: Given IV\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Leucovorin Calcium: Given IV\>
\> Oxaliplatin: Given IV\>
\> Paclitaxel: Given IV\>
\> Pembrolizumab: Given IV\>
\> Positron Emission Tomography: Undergo PET scan\>
\> Radiation Therapy: Undergo radiation therapy\>
\> Therapeutic Conventional Surgery: Undergo curative-intent surgery
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery)
n=31 Participants
See Detailed Description\>
\> Carboplatin: Given IV\>
\> Computed Tomography: Undergo CT scan\>
\> Fluorouracil: Given IV\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Leucovorin Calcium: Given IV\>
\> Oxaliplatin: Given IV\>
\> Paclitaxel: Given IV\>
\> Pembrolizumab: Given IV\>
\> Positron Emission Tomography: Undergo PET scan\>
\> Radiation Therapy: Undergo radiation therapy\>
\> Therapeutic Conventional Surgery: Undergo curative-intent surgery
|
|---|---|
|
Age, Continuous
|
62 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=93 Participants
|
|
Tumor Location
Gastroesophageal junction
|
29 Participants
n=93 Participants
|
|
Tumor Location
Gastric cardia
|
2 Participants
n=93 Participants
|
|
Histologic Grade (differentiation)
G2 (moderately differentiated)
|
18 Participants
n=93 Participants
|
|
Histologic Grade (differentiation)
G3 (poorly differentiated)
|
12 Participants
n=93 Participants
|
|
Histologic Grade (differentiation)
GX (grade cannot be assessed)
|
1 Participants
n=93 Participants
|
|
Clinical Tumor Stage
T2
|
2 Participants
n=93 Participants
|
|
Clinical Tumor Stage
T3
|
29 Participants
n=93 Participants
|
|
Clinical Nodal Stage
N0
|
4 Participants
n=93 Participants
|
|
Clinical Nodal Stage
N1
|
13 Participants
n=93 Participants
|
|
Clinical Nodal Stage
N2
|
12 Participants
n=93 Participants
|
|
Clinical Nodal Stage
N3
|
2 Participants
n=93 Participants
|
|
Signet Ring Cell Histology
Yes
|
6 Participants
n=93 Participants
|
|
Signet Ring Cell Histology
No
|
25 Participants
n=93 Participants
|
|
PD-L1 Combined Positive Score (CPS)
<1
|
11 Participants
n=93 Participants
|
|
PD-L1 Combined Positive Score (CPS)
1-9
|
11 Participants
n=93 Participants
|
|
PD-L1 Combined Positive Score (CPS)
≥10
|
8 Participants
n=93 Participants
|
|
PD-L1 Combined Positive Score (CPS)
Unknown
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsDefined as number of patients with pathologic complete responses (pCR) divided by total evaluable patients. pCR is defined as no recognized cancer and margins free of tumor as found by the pathologist following resection of the esophageal specimen and accompanying lymph nodes.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery)
n=31 Participants
See Detailed Description \>
\> Carboplatin: Given IV
\>
\> Computed Tomography: Undergo CT scan
\>
\> Fluorouracil: Given IV
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Leucovorin Calcium: Given IV
\>
\> Oxaliplatin: Given IV
\>
\> Paclitaxel: Given IV
\>
\> Pembrolizumab: Given IV
\>
\> Positron Emission Tomography: Undergo PET scan
\>
\> Radiation Therapy: Undergo radiation therapy
\>
\> Therapeutic Conventional Surgery: Undergo curative-intent surgery
|
|---|---|
|
Pathological Complete Response (PathCR) Rate
|
22.6 percentage of patients
Interval 11.4 to 39.8
|
SECONDARY outcome
Timeframe: Up to 3 yearsDefined as the number of patients who achieve R0 resection divided by total number of evaluable patients.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery)
n=31 Participants
See Detailed Description \>
\> Carboplatin: Given IV
\>
\> Computed Tomography: Undergo CT scan
\>
\> Fluorouracil: Given IV
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Leucovorin Calcium: Given IV
\>
\> Oxaliplatin: Given IV
\>
\> Paclitaxel: Given IV
\>
\> Pembrolizumab: Given IV
\>
\> Positron Emission Tomography: Undergo PET scan
\>
\> Radiation Therapy: Undergo radiation therapy
\>
\> Therapeutic Conventional Surgery: Undergo curative-intent surgery
|
|---|---|
|
Complete Resection With no Tumor Within 1 mm of the Resection Margins (R0) Rate
|
28 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All patients that achieved an R0
Defined as the time from the date of study registration to the date of death due to any cause
Outcome measures
| Measure |
Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery)
n=27 Participants
See Detailed Description \>
\> Carboplatin: Given IV
\>
\> Computed Tomography: Undergo CT scan
\>
\> Fluorouracil: Given IV
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Leucovorin Calcium: Given IV
\>
\> Oxaliplatin: Given IV
\>
\> Paclitaxel: Given IV
\>
\> Pembrolizumab: Given IV
\>
\> Positron Emission Tomography: Undergo PET scan
\>
\> Radiation Therapy: Undergo radiation therapy
\>
\> Therapeutic Conventional Surgery: Undergo curative-intent surgery
|
|---|---|
|
Disease-free Survival (DFS)
|
8.87 months
Interval 7.46 to
Upper limit on 95% confidence interval is not estimable (NE), due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All patients that achieved an R0
Defined as the time from the date of study registration to the date of 1st documented relapse/recurrence among patients who achieve R0 resection
Outcome measures
| Measure |
Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery)
n=27 Participants
See Detailed Description \>
\> Carboplatin: Given IV
\>
\> Computed Tomography: Undergo CT scan
\>
\> Fluorouracil: Given IV
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Leucovorin Calcium: Given IV
\>
\> Oxaliplatin: Given IV
\>
\> Paclitaxel: Given IV
\>
\> Pembrolizumab: Given IV
\>
\> Positron Emission Tomography: Undergo PET scan
\>
\> Radiation Therapy: Undergo radiation therapy
\>
\> Therapeutic Conventional Surgery: Undergo curative-intent surgery
|
|---|---|
|
Time to Relapse (TTR)
|
8.87 months
Interval 7.46 to
Upper limit on 95% confidence interval is not estimable (NE), due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: 2 yearsThe distribution of OS will be estimated using the method of Kaplan-Meier. Two-year OS rate and confidence interval will be estimated based on Kaplan-Meier curve.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery)
n=31 Participants
See Detailed Description \>
\> Carboplatin: Given IV
\>
\> Computed Tomography: Undergo CT scan
\>
\> Fluorouracil: Given IV
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Leucovorin Calcium: Given IV
\>
\> Oxaliplatin: Given IV
\>
\> Paclitaxel: Given IV
\>
\> Pembrolizumab: Given IV
\>
\> Positron Emission Tomography: Undergo PET scan
\>
\> Radiation Therapy: Undergo radiation therapy
\>
\> Therapeutic Conventional Surgery: Undergo curative-intent surgery
|
|---|---|
|
Overall Survival (OS) at Two Years
|
63.3 percentage of participants
Interval 47.4 to 84.4
|
SECONDARY outcome
Timeframe: 2 yearsThe distribution of PFS will be estimated using the method of Kaplan-Meier. Two-year PFS rate and confidence interval will be estimated based on Kaplan-Meier curve.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery)
n=31 Participants
See Detailed Description \>
\> Carboplatin: Given IV
\>
\> Computed Tomography: Undergo CT scan
\>
\> Fluorouracil: Given IV
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Leucovorin Calcium: Given IV
\>
\> Oxaliplatin: Given IV
\>
\> Paclitaxel: Given IV
\>
\> Pembrolizumab: Given IV
\>
\> Positron Emission Tomography: Undergo PET scan
\>
\> Radiation Therapy: Undergo radiation therapy
\>
\> Therapeutic Conventional Surgery: Undergo curative-intent surgery
|
|---|---|
|
Progression-free Survival (PFS) Rate at Two Years
|
16.7 percentage of participants
Interval 6.0 to 46.5
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The 16 eligible patients enrolled in the phase 1b portion of the study were assessed for DLTs.
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse events that are possibly, probably or definitely related to study treatments will be recorded for each patient.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery)
n=16 Participants
See Detailed Description \>
\> Carboplatin: Given IV
\>
\> Computed Tomography: Undergo CT scan
\>
\> Fluorouracil: Given IV
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Leucovorin Calcium: Given IV
\>
\> Oxaliplatin: Given IV
\>
\> Paclitaxel: Given IV
\>
\> Pembrolizumab: Given IV
\>
\> Positron Emission Tomography: Undergo PET scan
\>
\> Radiation Therapy: Undergo radiation therapy
\>
\> Therapeutic Conventional Surgery: Undergo curative-intent surgery
|
|---|---|
|
Number of Patients Experiencing Dose-limiting Toxicities (DLTs)
|
2 Participants
|
Adverse Events
Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery)
Serious events: 13 serious events
Other events: 31 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery)
n=31 participants at risk
Therapeutic Conventional Surgery: Undergo curative-intent surgery
|
|---|---|
|
Investigations
Lymphocyte count decreased
|
6.5%
2/31 • Number of events 2 • 3 years, 6 months
|
|
Investigations
Platelet count decreased
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Investigations
White blood cell decreased
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Nervous system disorders
Syncope
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Vascular disorders
Hypertension
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Vascular disorders
Hypotension
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Investigations
Investigations - Other, specify
|
6.5%
2/31 • Number of events 2 • 3 years, 6 months
|
|
Gastrointestinal disorders
Colitis
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
1/31 • Number of events 2 • 3 years, 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Enterocolitis
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Gastric perforation
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Ileus
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
General disorders
Fatigue
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
General disorders
Fever
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
General disorders
Non-cardiac chest pain
|
3.2%
1/31 • Number of events 2 • 3 years, 6 months
|
|
Infections and infestations
Enterocolitis infectious
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
6.5%
2/31 • Number of events 2 • 3 years, 6 months
|
|
Infections and infestations
Sepsis
|
9.7%
3/31 • Number of events 4 • 3 years, 6 months
|
|
Injury, poisoning and procedural complications
Esophageal anastomotic leak
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Blood and lymphatic system disorders
Hemolysis
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Cardiac disorders
Pericardial effusion
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Cardiac disorders
Pericarditis
|
3.2%
1/31 • Number of events 2 • 3 years, 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Eye disorders
Eye disorders - Other, specify
|
3.2%
1/31 • Number of events 2 • 3 years, 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Ascites
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
Other adverse events
| Measure |
Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery)
n=31 participants at risk
Therapeutic Conventional Surgery: Undergo curative-intent surgery
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.8%
8/31 • Number of events 11 • 3 years, 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Cardiac disorders
Myocarditis
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Cardiac disorders
Palpitations
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Cardiac disorders
Pericardial effusion
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Cardiac disorders
Sinus bradycardia
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
6.5%
2/31 • Number of events 2 • 3 years, 6 months
|
|
Endocrine disorders
Hyperthyroidism
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Endocrine disorders
Hypothyroidism
|
3.2%
1/31 • Number of events 2 • 3 years, 6 months
|
|
Gastrointestinal disorders
Constipation
|
64.5%
20/31 • Number of events 28 • 3 years, 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
58.1%
18/31 • Number of events 52 • 3 years, 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
19.4%
6/31 • Number of events 7 • 3 years, 6 months
|
|
Gastrointestinal disorders
Gastric fistula
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
12.9%
4/31 • Number of events 7 • 3 years, 6 months
|
|
Gastrointestinal disorders
Ileus
|
6.5%
2/31 • Number of events 2 • 3 years, 6 months
|
|
Gastrointestinal disorders
Mucositis oral
|
9.7%
3/31 • Number of events 3 • 3 years, 6 months
|
|
Gastrointestinal disorders
Nausea
|
83.9%
26/31 • Number of events 53 • 3 years, 6 months
|
|
Gastrointestinal disorders
Obstruction gastric
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Gastrointestinal disorders
Vomiting
|
45.2%
14/31 • Number of events 30 • 3 years, 6 months
|
|
General disorders
Fatigue
|
93.5%
29/31 • Number of events 166 • 3 years, 6 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
General disorders
Pain
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Hepatobiliary disorders
Cholecystitis
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Immune system disorders
Allergic reaction
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Infections and infestations
Abdominal infection
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Infections and infestations
Pelvic infection
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Infections and infestations
Sepsis
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Injury, poisoning and procedural complications
Esophageal anastomotic leak
|
6.5%
2/31 • Number of events 2 • 3 years, 6 months
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Investigations
Alanine aminotransferase increased
|
12.9%
4/31 • Number of events 5 • 3 years, 6 months
|
|
Investigations
Alkaline phosphatase increased
|
16.1%
5/31 • Number of events 6 • 3 years, 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
12.9%
4/31 • Number of events 6 • 3 years, 6 months
|
|
Investigations
Cardiac troponin I increased
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Investigations
Cardiac troponin T increased
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Investigations
Creatinine increased
|
19.4%
6/31 • Number of events 8 • 3 years, 6 months
|
|
Investigations
Investigations - Other, specify
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Investigations
Lymphocyte count decreased
|
80.6%
25/31 • Number of events 67 • 3 years, 6 months
|
|
Investigations
Neutrophil count decreased
|
51.6%
16/31 • Number of events 17 • 3 years, 6 months
|
|
Investigations
Platelet count decreased
|
51.6%
16/31 • Number of events 24 • 3 years, 6 months
|
|
Investigations
Weight loss
|
9.7%
3/31 • Number of events 7 • 3 years, 6 months
|
|
Investigations
White blood cell decreased
|
48.4%
15/31 • Number of events 18 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
19.4%
6/31 • Number of events 7 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.5%
2/31 • Number of events 2 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
2/31 • Number of events 3 • 3 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.2%
1/31 • Number of events 2 • 3 years, 6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
35.5%
11/31 • Number of events 36 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
1/31 • Number of events 3 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.5%
2/31 • Number of events 2 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
35.5%
11/31 • Number of events 25 • 3 years, 6 months
|
|
Vascular disorders
Hypertension
|
19.4%
6/31 • Number of events 11 • 3 years, 6 months
|
|
Vascular disorders
Hypotension
|
6.5%
2/31 • Number of events 2 • 3 years, 6 months
|
|
Vascular disorders
Thromboembolic event
|
3.2%
1/31 • Number of events 1 • 3 years, 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place