Trial Outcomes & Findings for IRX-2, Cyclophosphamide, and Pembrolizumab in Treating Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Cancer (NCT NCT03918499)
NCT ID: NCT03918499
Last Updated: 2023-03-23
Results Overview
Estimated using the product-limit method of Kaplan and Meier. From initial treatment until progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
From first day of study drug administration to disease progression or death, assessed up to 2 years
Results posted on
2023-03-23
Participant Flow
Participant milestones
| Measure |
Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2)
Participants receive 200 mg of pembrolizumab IV over 30 minutes on day 1. Participants also receive 300 mg/m2 of cyclophosphamide IV on day 1 and 230 or 460 units of IRX-2 SC for 10 days starting on day 4 during cycles 1, 5, 9, 13, 17, 21, 25, 29, and 33. Treatment repeats every 3 weeks for up to 35 cycles in the absence of disease or unacceptable toxicity.
IRX-2 is supplied as a pale yellow, sterile liquid for subcutaneous injection in a 2.0 ml single dose vial.
Cyclophosphamide: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IRX-2, Cyclophosphamide, and Pembrolizumab in Treating Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2)
n=9 Participants
Participants receive 200 mg of pembrolizumab IV over 30 minutes on day 1. Participants also receive 300 mg/m2 of cyclophosphamide IV on day 1 and 230 or 460 units of IRX-2 SC for 10 days starting on day 4 during cycles 1, 5, 9, 13, 17, 21, 25, 29, and 33. Treatment repeats every 3 weeks for up to 35 cycles in the absence of disease or unacceptable toxicity.
IRX-2 is supplied as a pale yellow, sterile liquid for subcutaneous injection in a 2.0 ml single dose vial.
Cyclophosphamide: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
|
Tumor Stage @ Diagnosis
II
|
2 Participants
n=5 Participants
|
|
Tumor Stage @ Diagnosis
IV
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first day of study drug administration to disease progression or death, assessed up to 2 yearsEstimated using the product-limit method of Kaplan and Meier. From initial treatment until progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2)
n=9 Participants
Participants receive 200 mg of pembrolizumab IV over 30 minutes on day 1. Participants also receive 300 mg/m2 of cyclophosphamide IV on day 1 and 230 or 460 units of IRX-2 SC for 10 days starting on day 4 during cycles 1, 5, 9, 13, 17, 21, 25, 29, and 33. Treatment repeats every 3 weeks for up to 35 cycles in the absence of disease or unacceptable toxicity.
IRX-2 is supplied as a pale yellow, sterile liquid for subcutaneous injection in a 2.0 ml single dose vial.
Cyclophosphamide: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Progression-free Survival
|
1.1 Months
Interval 0.4 to 2.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsEstimated using the product-limit method of Kaplan and Meier. From the time of initial treatment until death from any cause.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2)
n=9 Participants
Participants receive 200 mg of pembrolizumab IV over 30 minutes on day 1. Participants also receive 300 mg/m2 of cyclophosphamide IV on day 1 and 230 or 460 units of IRX-2 SC for 10 days starting on day 4 during cycles 1, 5, 9, 13, 17, 21, 25, 29, and 33. Treatment repeats every 3 weeks for up to 35 cycles in the absence of disease or unacceptable toxicity.
IRX-2 is supplied as a pale yellow, sterile liquid for subcutaneous injection in a 2.0 ml single dose vial.
Cyclophosphamide: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Overall Survival
|
2.9 Months
Interval 0.4 to 8.7
|
SECONDARY outcome
Timeframe: Up to 2 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2)
n=9 Participants
Participants receive 200 mg of pembrolizumab IV over 30 minutes on day 1. Participants also receive 300 mg/m2 of cyclophosphamide IV on day 1 and 230 or 460 units of IRX-2 SC for 10 days starting on day 4 during cycles 1, 5, 9, 13, 17, 21, 25, 29, and 33. Treatment repeats every 3 weeks for up to 35 cycles in the absence of disease or unacceptable toxicity.
IRX-2 is supplied as a pale yellow, sterile liquid for subcutaneous injection in a 2.0 ml single dose vial.
Cyclophosphamide: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Overall Response
|
0 Participants
|
Adverse Events
Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2)
n=9 participants at risk
Participants receive 200 mg of pembrolizumab IV over 30 minutes on day 1. Participants also receive 300 mg/m2 of cyclophosphamide IV on day 1 and 230 or 460 units of IRX-2 SC for 10 days starting on day 4 during cycles 1, 5, 9, 13, 17, 21, 25, 29, and 33. Treatment repeats every 3 weeks for up to 35 cycles in the absence of disease or unacceptable toxicity.
IRX-2 is supplied as a pale yellow, sterile liquid for subcutaneous injection in a 2.0 ml single dose vial.
Cyclophosphamide: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Cardiac disorders
Pericardial effusion
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2)
n=9 participants at risk
Participants receive 200 mg of pembrolizumab IV over 30 minutes on day 1. Participants also receive 300 mg/m2 of cyclophosphamide IV on day 1 and 230 or 460 units of IRX-2 SC for 10 days starting on day 4 during cycles 1, 5, 9, 13, 17, 21, 25, 29, and 33. Treatment repeats every 3 weeks for up to 35 cycles in the absence of disease or unacceptable toxicity.
IRX-2 is supplied as a pale yellow, sterile liquid for subcutaneous injection in a 2.0 ml single dose vial.
Cyclophosphamide: Given IV
Pembrolizumab: Given IV
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
22.2%
2/9 • Number of events 5 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.2%
2/9 • Number of events 5 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
11.1%
1/9 • Number of events 2 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
1/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Excessive Sweating
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
11.1%
1/9 • Number of events 5 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Rash-Waist
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin rash-Waist
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Surgical and medical procedures
Bleeding at right injection site
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Surgical and medical procedures
Soreness at injection site
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
10020772-Hypertension
|
55.6%
5/9 • Number of events 20 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
10021097-Hypotension
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
9/9 • Number of events 24 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Pericardial effusion
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
22.2%
2/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Tricuspid valve disease
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Mitral valve disease
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Pulmonary valve disease
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Aortic valve disease
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Abnormal QRS-T angle, consider primary T
|
11.1%
1/9 • Number of events 2 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Non-specific T Wave Abnormality
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
ST and T Wave Abnormality
|
11.1%
1/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus Bradycardia
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
T Wave Abnormality
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Tachycardia
|
11.1%
1/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
10005886-Blurred vision
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Glaucoma
|
11.1%
1/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Double Vision
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Double vision
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Retinal Hemorrhage
|
11.1%
1/9 • Number of events 5 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Swelling around the eye
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
55.6%
5/9 • Number of events 13 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Ascites
|
22.2%
2/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Bloating
|
11.1%
1/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
55.6%
5/9 • Number of events 15 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
4/9 • Number of events 5 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
55.6%
5/9 • Number of events 13 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
77.8%
7/9 • Number of events 12 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
44.4%
4/9 • Number of events 12 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
22.2%
2/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Acid Reflux
|
11.1%
1/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Early Satiety
|
11.1%
1/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Teeth Sensitivity
|
11.1%
1/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
77.8%
7/9 • Number of events 26 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
22.2%
2/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Flu like symptoms
|
11.1%
1/9 • Number of events 2 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
33.3%
3/9 • Number of events 12 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
33.3%
3/9 • Number of events 9 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Non-cardiac chest pain
|
11.1%
1/9 • Number of events 2 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Left Lower Extremity Edema
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Endocarditis infective
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sepsis
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
11.1%
1/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Activated partial thromboplasti
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increa
|
22.2%
2/9 • Number of events 6 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
77.8%
7/9 • Number of events 23 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase incr
|
22.2%
2/9 • Number of events 8 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Number of events 2 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count decreased
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
22.2%
2/9 • Number of events 7 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Thyroid stimulating hormone inc
|
33.3%
3/9 • Number of events 10 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
White blood cell decreased
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hyperchloremia
|
22.2%
2/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hypochloremia
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hypochlorinemia
|
22.2%
2/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hypoproteinemia
|
44.4%
4/9 • Number of events 7 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hypoprotenemia
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet Count Increased
|
11.1%
1/9 • Number of events 2 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platet Count Increased
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
6/9 • Number of events 21 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
3/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
77.8%
7/9 • Number of events 24 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
6/9 • Number of events 24 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
3/9 • Number of events 6 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
6/9 • Number of events 21 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
11.1%
1/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
3/9 • Number of events 9 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Left Arm Weakness
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dysgeusia
|
11.1%
1/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 5 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
77.8%
7/9 • Number of events 22 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary retention
|
11.1%
1/9 • Number of events 3 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.4%
4/9 • Number of events 13 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
44.4%
4/9 • Number of events 10 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
22.2%
2/9 • Number of events 7 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
22.2%
2/9 • Number of events 5 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
22.2%
2/9 • Number of events 7 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
1/9 • Number of events 4 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
11.1%
1/9 • Number of events 1 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chest Congestion
|
11.1%
1/9 • Number of events 2 • Adverse events occurred over a period of 2 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place