Trial Outcomes & Findings for Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas (NCT NCT03783936)
NCT ID: NCT03783936
Last Updated: 2023-12-19
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter(LD) of target lesions; Progressive Disease (PD): \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. The bORR will be defined as the percentage of subjects whose best response by 24 weeks are either a CR or PR according to RECIST 1.1. For confirmed response, PR or CR need to be confirmed by repeat assessments that should be performed no less than 4 weeks. Otherwise, it will be considered as an unconfirmed response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
24 weeks
Results posted on
2023-12-19
Participant Flow
Participant milestones
| Measure |
Induction and Maintenance
Cycles 1-9; Induction; Cycle = 14 days
mFOLFOX6
* oxaliplatin 85 mg/m2 IV Day 1 and
* leucovorin 400 mg/m2 IV Day 1 and
* 5 fluorouracil 400 mg/m2 IV bolus and 2400 mg/m2 IV over 46 hours Day 1 and
Trastuzumab 6 mg/kg IV loading dose C1D1 then Trastuzumab 4 mg/kg IV Day 1 and
Avelumab 800 mg IV Day 1
Cycles 10 and subsequent; Maintenance; Cycle = 14 days
Trastuzumab 4 mg/kg Day 1 and Avelumab 800 mg Day 1
Oxaliplatin: Oxaliplatin 85 mg/m2
Leucovorin: Leucovorin 400 mg/m2
5 fluorouracil: 5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion
Trastuzumab: Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1
Avelumab: Avelumab 800 mg
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas
Baseline characteristics by cohort
| Measure |
Induction and Maintenance
n=18 Participants
Cycles 1-9; Induction; Cycle = 14 days
mFOLFOX6
* oxaliplatin 85 mg/m2 IV Day 1 and
* leucovorin 400 mg/m2 IV Day 1 and
* 5 fluorouracil 400 mg/m2 IV bolus and 2400 mg/m2 IV over 46 hours Day 1 and
Trastuzumab 6 mg/kg IV loading dose C1D1 then Trastuzumab 4 mg/kg IV Day 1 and
Avelumab 800 mg IV Day 1
Cycles 10 and subsequent; Maintenance; Cycle = 14 days
Trastuzumab 4 mg/kg Day 1 and Avelumab 800 mg Day 1
Oxaliplatin: Oxaliplatin 85 mg/m2
Leucovorin: Leucovorin 400 mg/m2
5 fluorouracil: 5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion
Trastuzumab: Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1
Avelumab: Avelumab 800 mg
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
|
Primary Tumor Site
Esophagus
|
4 Participants
n=5 Participants
|
|
Primary Tumor Site
Gastroesophageal Junction
|
8 Participants
n=5 Participants
|
|
Primary Tumor Site
Stomach
|
4 Participants
n=5 Participants
|
|
Primary Tumor Site
Not described or multiple
|
2 Participants
n=5 Participants
|
|
HER2 IHC
3 +
|
12 Participants
n=5 Participants
|
|
HER2 IHC
2+ with ISH (in situ hybridization) +
|
6 Participants
n=5 Participants
|
|
Programmed cell death ligand 1(PD-L1) CPS Score
CPS = 0
|
4 Participants
n=5 Participants
|
|
Programmed cell death ligand 1(PD-L1) CPS Score
CPS = 1 to <5
|
5 Participants
n=5 Participants
|
|
Programmed cell death ligand 1(PD-L1) CPS Score
CPS = 5 to <10
|
4 Participants
n=5 Participants
|
|
Programmed cell death ligand 1(PD-L1) CPS Score
CPS ≥ 10
|
4 Participants
n=5 Participants
|
|
Programmed cell death ligand 1(PD-L1) CPS Score
Unknown
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter(LD) of target lesions; Progressive Disease (PD): \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. The bORR will be defined as the percentage of subjects whose best response by 24 weeks are either a CR or PR according to RECIST 1.1. For confirmed response, PR or CR need to be confirmed by repeat assessments that should be performed no less than 4 weeks. Otherwise, it will be considered as an unconfirmed response.
Outcome measures
| Measure |
Induction and Maintenance
n=18 Participants
Cycles 1-9; Induction; Cycle = 14 days
mFOLFOX6
* oxaliplatin 85 mg/m2 IV Day 1 and
* leucovorin 400 mg/m2 IV Day 1 and
* 5 fluorouracil 400 mg/m2 IV bolus and 2400 mg/m2 IV over 46 hours Day 1 and
Trastuzumab 6 mg/kg IV loading dose C1D1 then Trastuzumab 4 mg/kg IV Day 1 and
Avelumab 800 mg IV Day 1
Cycles 10 and subsequent; Maintenance; Cycle = 14 days
Trastuzumab 4 mg/kg Day 1 and Avelumab 800 mg Day 1
Oxaliplatin: Oxaliplatin 85 mg/m2
Leucovorin: Leucovorin 400 mg/m2
5 fluorouracil: 5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion
Trastuzumab: Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1
Avelumab: Avelumab 800 mg
|
|---|---|
|
Best Objective Response Rate (bORR)
Best response rate (confirmed or unconfirmed)
|
61 Percentage of participants
Interval 39.0 to 84.0
|
|
Best Objective Response Rate (bORR)
Best confirmed response rate
|
50 Percentage of participants
Interval 29.0 to 71.0
|
SECONDARY outcome
Timeframe: Time of treatment start until the criteria for disease progression or death, up to a maximum of 11 months.Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter(LD) of target lesions; Progressive Disease (PD): \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progression Free Survival (PFS) will be defined as the time from the start date of treatment to the date of documented progression as determined by RECIST 1.1 or death from any cause.
Outcome measures
| Measure |
Induction and Maintenance
n=18 Participants
Cycles 1-9; Induction; Cycle = 14 days
mFOLFOX6
* oxaliplatin 85 mg/m2 IV Day 1 and
* leucovorin 400 mg/m2 IV Day 1 and
* 5 fluorouracil 400 mg/m2 IV bolus and 2400 mg/m2 IV over 46 hours Day 1 and
Trastuzumab 6 mg/kg IV loading dose C1D1 then Trastuzumab 4 mg/kg IV Day 1 and
Avelumab 800 mg IV Day 1
Cycles 10 and subsequent; Maintenance; Cycle = 14 days
Trastuzumab 4 mg/kg Day 1 and Avelumab 800 mg Day 1
Oxaliplatin: Oxaliplatin 85 mg/m2
Leucovorin: Leucovorin 400 mg/m2
5 fluorouracil: 5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion
Trastuzumab: Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1
Avelumab: Avelumab 800 mg
|
|---|---|
|
Progression Free Survival (PFS)
|
8 months
Interval 5.3 to
The upper limit could not be reached due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Time of treatment start until the criteria for disease progression or death, up to a maximum of 11 months.Immune-RECIST Criteria(iRECIST): Complete Response(iCR), Disappearance of all measurable and non-measurable lesions; Partial Response (iPR), \>=30% decrease in tumor burden relative to baseline; Unconfirmed Progressive Disease (iUPD), \>= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Confirmed Progressive Disease (iCPD), confirmation of iUPD (by further growth) at the next assessment; Stable Disease (iSD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. iPFS will be defined as the time from the start date of treatment to the date of documented progression as determined by iRECIST criteria or death from any cause.
Outcome measures
| Measure |
Induction and Maintenance
n=18 Participants
Cycles 1-9; Induction; Cycle = 14 days
mFOLFOX6
* oxaliplatin 85 mg/m2 IV Day 1 and
* leucovorin 400 mg/m2 IV Day 1 and
* 5 fluorouracil 400 mg/m2 IV bolus and 2400 mg/m2 IV over 46 hours Day 1 and
Trastuzumab 6 mg/kg IV loading dose C1D1 then Trastuzumab 4 mg/kg IV Day 1 and
Avelumab 800 mg IV Day 1
Cycles 10 and subsequent; Maintenance; Cycle = 14 days
Trastuzumab 4 mg/kg Day 1 and Avelumab 800 mg Day 1
Oxaliplatin: Oxaliplatin 85 mg/m2
Leucovorin: Leucovorin 400 mg/m2
5 fluorouracil: 5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion
Trastuzumab: Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1
Avelumab: Avelumab 800 mg
|
|---|---|
|
Progression Free Survival by iRECIST(iPFS)
|
8 months
Interval 5.3 to
The upper limit could not be reached due to the insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Time of treatment start until death or date of last contact, up to a maximum of 20 monthsOverall Survival (OS) will be defined as the time from start of treatment to the date of death from any cause, or date of last contact (censored).
Outcome measures
| Measure |
Induction and Maintenance
n=18 Participants
Cycles 1-9; Induction; Cycle = 14 days
mFOLFOX6
* oxaliplatin 85 mg/m2 IV Day 1 and
* leucovorin 400 mg/m2 IV Day 1 and
* 5 fluorouracil 400 mg/m2 IV bolus and 2400 mg/m2 IV over 46 hours Day 1 and
Trastuzumab 6 mg/kg IV loading dose C1D1 then Trastuzumab 4 mg/kg IV Day 1 and
Avelumab 800 mg IV Day 1
Cycles 10 and subsequent; Maintenance; Cycle = 14 days
Trastuzumab 4 mg/kg Day 1 and Avelumab 800 mg Day 1
Oxaliplatin: Oxaliplatin 85 mg/m2
Leucovorin: Leucovorin 400 mg/m2
5 fluorouracil: 5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion
Trastuzumab: Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1
Avelumab: Avelumab 800 mg
|
|---|---|
|
Overall Survival (OS)
|
13.1 months
Interval 11.5 to
The upper limit could not be reached due to the insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to a maximum of 11 months.Disease Control Rate (DCR) will be defined as the total number of patients whose best responses are either a CR, PR, or SD divided by the number of response evaluable patients. Patients with best response of SD will need to maintain SD by 24 weeks to be considered to have received clinical benefit from the treatment regimen.
Outcome measures
| Measure |
Induction and Maintenance
n=18 Participants
Cycles 1-9; Induction; Cycle = 14 days
mFOLFOX6
* oxaliplatin 85 mg/m2 IV Day 1 and
* leucovorin 400 mg/m2 IV Day 1 and
* 5 fluorouracil 400 mg/m2 IV bolus and 2400 mg/m2 IV over 46 hours Day 1 and
Trastuzumab 6 mg/kg IV loading dose C1D1 then Trastuzumab 4 mg/kg IV Day 1 and
Avelumab 800 mg IV Day 1
Cycles 10 and subsequent; Maintenance; Cycle = 14 days
Trastuzumab 4 mg/kg Day 1 and Avelumab 800 mg Day 1
Oxaliplatin: Oxaliplatin 85 mg/m2
Leucovorin: Leucovorin 400 mg/m2
5 fluorouracil: 5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion
Trastuzumab: Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1
Avelumab: Avelumab 800 mg
|
|---|---|
|
Disease Control Rate (DCR)
|
55.6 Percentage of participants
|
SECONDARY outcome
Timeframe: AE had been recorded from time of signed informed consent until 30 days after discontinuation of study drug(s) and/or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 20 months.The frequency and severity of all grade 3-4 treatment related adverse events are reported by CTCAE v5.
Outcome measures
| Measure |
Induction and Maintenance
n=18 Participants
Cycles 1-9; Induction; Cycle = 14 days
mFOLFOX6
* oxaliplatin 85 mg/m2 IV Day 1 and
* leucovorin 400 mg/m2 IV Day 1 and
* 5 fluorouracil 400 mg/m2 IV bolus and 2400 mg/m2 IV over 46 hours Day 1 and
Trastuzumab 6 mg/kg IV loading dose C1D1 then Trastuzumab 4 mg/kg IV Day 1 and
Avelumab 800 mg IV Day 1
Cycles 10 and subsequent; Maintenance; Cycle = 14 days
Trastuzumab 4 mg/kg Day 1 and Avelumab 800 mg Day 1
Oxaliplatin: Oxaliplatin 85 mg/m2
Leucovorin: Leucovorin 400 mg/m2
5 fluorouracil: 5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion
Trastuzumab: Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1
Avelumab: Avelumab 800 mg
|
|---|---|
|
Number of Participants With Grade 3-4 Treatment Related Adverse Events
Neutrophil count decreased
|
6 Participants
|
|
Number of Participants With Grade 3-4 Treatment Related Adverse Events
Platelet count decreased
|
2 Participants
|
|
Number of Participants With Grade 3-4 Treatment Related Adverse Events
Anemia
|
2 Participants
|
|
Number of Participants With Grade 3-4 Treatment Related Adverse Events
White blood cell decreased
|
1 Participants
|
|
Number of Participants With Grade 3-4 Treatment Related Adverse Events
Lymphocyte count decreased
|
1 Participants
|
|
Number of Participants With Grade 3-4 Treatment Related Adverse Events
Hypokalemia
|
2 Participants
|
|
Number of Participants With Grade 3-4 Treatment Related Adverse Events
Diarrhea
|
2 Participants
|
|
Number of Participants With Grade 3-4 Treatment Related Adverse Events
Gastroesophageal reflux disease
|
1 Participants
|
|
Number of Participants With Grade 3-4 Treatment Related Adverse Events
Lung infection
|
1 Participants
|
|
Number of Participants With Grade 3-4 Treatment Related Adverse Events
Mucositis oral
|
1 Participants
|
Adverse Events
Induction and Maintenance
Serious events: 7 serious events
Other events: 18 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Induction and Maintenance
n=18 participants at risk
Cycles 1-9; Induction; Cycle = 14 days
mFOLFOX6
* oxaliplatin 85 mg/m2 IV Day 1 and
* leucovorin 400 mg/m2 IV Day 1 and
* 5 fluorouracil 400 mg/m2 IV bolus and 2400 mg/m2 IV over 46 hours Day 1 and
Trastuzumab 6 mg/kg IV loading dose C1D1 then Trastuzumab 4 mg/kg IV Day 1 and
Avelumab 800 mg IV Day 1
Cycles 10 and subsequent; Maintenance; Cycle = 14 days
Trastuzumab 4 mg/kg Day 1 and Avelumab 800 mg Day 1
Oxaliplatin: Oxaliplatin 85 mg/m2
Leucovorin: Leucovorin 400 mg/m2
5 fluorouracil: 5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion
Trastuzumab: Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1
Avelumab: Avelumab 800 mg
|
|---|---|
|
Cardiac disorders
CARDIAC ARREST
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Nervous system disorders
DIZZINESS
|
5.6%
1/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
Injury, poisoning and procedural complications
FALL
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Vascular disorders
HEMATOMA
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Infections and infestations
LUNG INFECTION
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
NAUSEA
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
OBSTRUCTION GASTRIC
|
5.6%
1/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
Investigations
PLATELET COUNT DECREASED
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Infections and infestations
SEPSIS
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOR HEMORRHAGE
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
VOMITING
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
Other adverse events
| Measure |
Induction and Maintenance
n=18 participants at risk
Cycles 1-9; Induction; Cycle = 14 days
mFOLFOX6
* oxaliplatin 85 mg/m2 IV Day 1 and
* leucovorin 400 mg/m2 IV Day 1 and
* 5 fluorouracil 400 mg/m2 IV bolus and 2400 mg/m2 IV over 46 hours Day 1 and
Trastuzumab 6 mg/kg IV loading dose C1D1 then Trastuzumab 4 mg/kg IV Day 1 and
Avelumab 800 mg IV Day 1
Cycles 10 and subsequent; Maintenance; Cycle = 14 days
Trastuzumab 4 mg/kg Day 1 and Avelumab 800 mg Day 1
Oxaliplatin: Oxaliplatin 85 mg/m2
Leucovorin: Leucovorin 400 mg/m2
5 fluorouracil: 5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion
Trastuzumab: Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1
Avelumab: Avelumab 800 mg
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
27.8%
5/18 • Number of events 8 • Up to a maximum of 20 months.
|
|
Psychiatric disorders
AGITATION
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
33.3%
6/18 • Number of events 10 • Up to a maximum of 20 months.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Blood and lymphatic system disorders
ANEMIA
|
61.1%
11/18 • Number of events 35 • Up to a maximum of 20 months.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
50.0%
9/18 • Number of events 13 • Up to a maximum of 20 months.
|
|
Psychiatric disorders
ANXIETY
|
11.1%
2/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.7%
3/18 • Number of events 6 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
ASCITES
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.7%
3/18 • Number of events 8 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
BELCHING
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
16.7%
3/18 • Number of events 5 • Up to a maximum of 20 months.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Injury, poisoning and procedural complications
BRUISING
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Cardiac disorders
CARDIAC DISORDERS - OTHER, SPECIFY
|
11.1%
2/18 • Number of events 6 • Up to a maximum of 20 months.
|
|
General disorders
CHILLS
|
22.2%
4/18 • Number of events 4 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
COLITIS
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
44.4%
8/18 • Number of events 10 • Up to a maximum of 20 months.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
27.8%
5/18 • Number of events 5 • Up to a maximum of 20 months.
|
|
Investigations
CREATININE INCREASED
|
22.2%
4/18 • Number of events 4 • Up to a maximum of 20 months.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
16.7%
3/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
Psychiatric disorders
DEPRESSION
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
DIARRHEA
|
44.4%
8/18 • Number of events 25 • Up to a maximum of 20 months.
|
|
Nervous system disorders
DIZZINESS
|
22.2%
4/18 • Number of events 5 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
DRY MOUTH
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Nervous system disorders
DYSESTHESIA
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Nervous system disorders
DYSGEUSIA
|
33.3%
6/18 • Number of events 10 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
16.7%
3/18 • Number of events 11 • Up to a maximum of 20 months.
|
|
Nervous system disorders
DYSPHASIA
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
General disorders
EDEMA FACE
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
General disorders
EDEMA LIMBS
|
22.2%
4/18 • Number of events 7 • Up to a maximum of 20 months.
|
|
Investigations
EJECTION FRACTION DECREASED
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Blood and lymphatic system disorders
EOSINOPHILIA
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
11.1%
2/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
ESOPHAGEAL PAIN
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Injury, poisoning and procedural complications
FALL
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
General disorders
FATIGUE
|
61.1%
11/18 • Number of events 18 • Up to a maximum of 20 months.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
General disorders
FEVER
|
11.1%
2/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
FLATULENCE
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
General disorders
GAIT DISTURBANCE
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
16.7%
3/18 • Number of events 7 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
22.2%
4/18 • Number of events 5 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY
|
16.7%
3/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
11.1%
2/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
Nervous system disorders
HEADACHE
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Ear and labyrinth disorders
HEARING IMPAIRED
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Vascular disorders
HEMATOMA
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Blood and lymphatic system disorders
HEMOLYTIC UREMIC SYNDROME
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Vascular disorders
HOT FLASHES
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Vascular disorders
HYPERTENSION
|
38.9%
7/18 • Number of events 90 • Up to a maximum of 20 months.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
33.3%
6/18 • Number of events 20 • Up to a maximum of 20 months.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
27.8%
5/18 • Number of events 10 • Up to a maximum of 20 months.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
27.8%
5/18 • Number of events 10 • Up to a maximum of 20 months.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
27.8%
5/18 • Number of events 10 • Up to a maximum of 20 months.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
16.7%
3/18 • Number of events 8 • Up to a maximum of 20 months.
|
|
Vascular disorders
HYPOTENSION
|
11.1%
2/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
General disorders
HYPOTHERMIA
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
11.1%
2/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
22.2%
4/18 • Number of events 9 • Up to a maximum of 20 months.
|
|
Injury, poisoning and procedural complications
INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY
|
16.7%
3/18 • Number of events 4 • Up to a maximum of 20 months.
|
|
Psychiatric disorders
INSOMNIA
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Investigations
INVESTIGATIONS - OTHER, SPECIFY
|
11.1%
2/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
General disorders
LOCALIZED EDEMA
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
27.8%
5/18 • Number of events 14 • Up to a maximum of 20 months.
|
|
General disorders
MALAISE
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
22.2%
4/18 • Number of events 7 • Up to a maximum of 20 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY
|
16.7%
3/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
NAUSEA
|
50.0%
9/18 • Number of events 18 • Up to a maximum of 20 months.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
61.1%
11/18 • Number of events 27 • Up to a maximum of 20 months.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
5.6%
1/18 • Number of events 4 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
ORAL PAIN
|
5.6%
1/18 • Number of events 4 • Up to a maximum of 20 months.
|
|
General disorders
PAIN
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
11.1%
2/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Cardiac disorders
PALPITATIONS
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Nervous system disorders
PARESTHESIA
|
16.7%
3/18 • Number of events 7 • Up to a maximum of 20 months.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
66.7%
12/18 • Number of events 21 • Up to a maximum of 20 months.
|
|
Investigations
PLATELET COUNT DECREASED
|
50.0%
9/18 • Number of events 16 • Up to a maximum of 20 months.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Nervous system disorders
PRESYNCOPE
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
16.7%
3/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
22.2%
4/18 • Number of events 5 • Up to a maximum of 20 months.
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS - OTHER, SPECIFY
|
11.1%
2/18 • Number of events 3 • Up to a maximum of 20 months.
|
|
Renal and urinary disorders
RENAL CALCULI
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHEA
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Nervous system disorders
SEIZURE
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
5.6%
1/18 • Number of events 7 • Up to a maximum of 20 months.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
16.7%
3/18 • Number of events 4 • Up to a maximum of 20 months.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
16.7%
3/18 • Number of events 5 • Up to a maximum of 20 months.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
STOMACH PAIN
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Investigations
THYROID STIMULATING HORMONE INCREASED
|
11.1%
2/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Ear and labyrinth disorders
TINNITUS
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOR HEMORRHAGE
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Renal and urinary disorders
URINARY RETENTION
|
16.7%
3/18 • Number of events 4 • Up to a maximum of 20 months.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Injury, poisoning and procedural complications
UROSTOMY OBSTRUCTION
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
|
Gastrointestinal disorders
VOMITING
|
38.9%
7/18 • Number of events 12 • Up to a maximum of 20 months.
|
|
Investigations
WEIGHT GAIN
|
5.6%
1/18 • Number of events 2 • Up to a maximum of 20 months.
|
|
Investigations
WEIGHT LOSS
|
44.4%
8/18 • Number of events 16 • Up to a maximum of 20 months.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
33.3%
6/18 • Number of events 29 • Up to a maximum of 20 months.
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
5.6%
1/18 • Number of events 1 • Up to a maximum of 20 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place