Trial Outcomes & Findings for Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma (NCT NCT00948935)
NCT ID: NCT00948935
Last Updated: 2020-03-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
5 months
Results posted on
2020-03-11
Participant Flow
Participant milestones
| Measure |
Chemotherapy
Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Chemotherapy
n=35 Participants
Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 monthsOutcome measures
| Measure |
Chemotherapy
n=35 Participants
Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
|
|---|---|
|
Progression Free Survival Rate at Five Months
|
69 percentage of participants
|
SECONDARY outcome
Timeframe: 5 monthsOutcome measures
| Measure |
Chemotherapy
n=35 Participants
Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
|
|---|---|
|
Response Rate From Combination Chemotherapy
Complete Response
|
2 Participants
|
|
Response Rate From Combination Chemotherapy
Partial Response
|
9 Participants
|
|
Response Rate From Combination Chemotherapy
Stable Disease
|
15 Participants
|
|
Response Rate From Combination Chemotherapy
Progressive Disease
|
2 Participants
|
|
Response Rate From Combination Chemotherapy
Not Assessable
|
7 Participants
|
Adverse Events
Chemotherapy
Serious events: 21 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemotherapy
n=35 participants at risk
Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
|
|---|---|
|
Cardiac disorders
Cardiac Arrhythmia
|
2.9%
1/35 • Number of events 1
|
|
General disorders
Fatigue
|
2.9%
1/35 • Number of events 1
|
|
General disorders
Fever
|
11.4%
4/35 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
14.3%
5/35 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
5.7%
2/35 • Number of events 2
|
|
Gastrointestinal disorders
Free Air
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Obstruction, GI
|
8.6%
3/35 • Number of events 5
|
|
Infections and infestations
Abdomen NOS
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Febrile Neutropenia
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Neurological Meningitis
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.9%
1/35 • Number of events 1
|
|
Nervous system disorders
Confusion
|
2.9%
1/35 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
2.9%
1/35 • Number of events 2
|
|
Nervous system disorders
Syncope (fainting)
|
2.9%
1/35 • Number of events 2
|
|
General disorders
Pain
|
2.9%
1/35 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/35 • Number of events 1
|
|
Reproductive system and breast disorders
chronic obstructive pulmonary disease
|
2.9%
1/35 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.9%
1/35 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
2.9%
1/35 • Number of events 1
|
|
Vascular disorders
Peripheral arterial ischemia
|
2.9%
1/35 • Number of events 2
|
|
Vascular disorders
Thrombosis/thombus/embolism
|
11.4%
4/35 • Number of events 8
|
Other adverse events
| Measure |
Chemotherapy
n=35 participants at risk
Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
|
|---|---|
|
Metabolism and nutrition disorders
hypoglymcemia
|
34.3%
12/35 • Number of events 30
|
|
Musculoskeletal and connective tissue disorders
carpal tunel
|
2.9%
1/35 • Number of events 1
|
|
Nervous system disorders
hand tremors
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
2.9%
1/35 • Number of events 1
|
|
Nervous system disorders
headache
|
31.4%
11/35 • Number of events 12
|
|
Gastrointestinal disorders
bloating
|
14.3%
5/35 • Number of events 5
|
|
Gastrointestinal disorders
abdominal cramping
|
2.9%
1/35 • Number of events 2
|
|
Gastrointestinal disorders
abdominal fullness
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
abdominal pain
|
45.7%
16/35 • Number of events 18
|
|
Metabolism and nutrition disorders
acidosis
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
acne-form
|
5.7%
2/35 • Number of events 2
|
|
Vascular disorders
acute arterial occulsion LLE
|
2.9%
1/35 • Number of events 1
|
|
General disorders
infusion reaction
|
8.6%
3/35 • Number of events 3
|
|
Renal and urinary disorders
acute renal failure
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
80.0%
28/35 • Number of events 107
|
|
Metabolism and nutrition disorders
alkaline phosphatase (high)
|
62.9%
22/35 • Number of events 59
|
|
Metabolism and nutrition disorders
alkalosis
|
2.9%
1/35 • Number of events 1
|
|
Immune system disorders
allergic rhinitis
|
2.9%
1/35 • Number of events 1
|
|
Immune system disorders
tape allergy
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
alopecia
|
54.3%
19/35 • Number of events 20
|
|
Metabolism and nutrition disorders
Alanine Aminotransferase (high)
|
45.7%
16/35 • Number of events 35
|
|
Metabolism and nutrition disorders
amylase (high)
|
2.9%
1/35 • Number of events 1
|
|
Blood and lymphatic system disorders
neutropenia
|
57.1%
20/35 • Number of events 90
|
|
Gastrointestinal disorders
anorexia
|
37.1%
13/35 • Number of events 17
|
|
Psychiatric disorders
anxiety
|
25.7%
9/35 • Number of events 10
|
|
Infections and infestations
ascending cholangitis
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
ascites
|
11.4%
4/35 • Number of events 4
|
|
Metabolism and nutrition disorders
Aspartate Aminotransferase (high)
|
68.6%
24/35 • Number of events 55
|
|
Respiratory, thoracic and mediastinal disorders
atelectasis
|
2.9%
1/35 • Number of events 1
|
|
Blood and lymphatic system disorders
edema
|
48.6%
17/35 • Number of events 42
|
|
Musculoskeletal and connective tissue disorders
back pain
|
34.3%
12/35 • Number of events 22
|
|
Gastrointestinal disorders
belching
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
31.4%
11/35 • Number of events 14
|
|
Metabolism and nutrition disorders
bilirubin (high)
|
48.6%
17/35 • Number of events 32
|
|
Vascular disorders
hemorrhoids
|
2.9%
1/35 • Number of events 1
|
|
Eye disorders
blurred vision
|
8.6%
3/35 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Body Aches
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
low calcium
|
80.0%
28/35 • Number of events 94
|
|
Metabolism and nutrition disorders
high calcium
|
5.7%
2/35 • Number of events 3
|
|
Infections and infestations
cellulitis
|
2.9%
1/35 • Number of events 1
|
|
Nervous system disorders
cerebro-vascular ischemia
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
cheliosis
|
8.6%
3/35 • Number of events 3
|
|
General disorders
Chills
|
11.4%
4/35 • Number of events 6
|
|
Immune system disorders
cold (respiratory)
|
2.9%
1/35 • Number of events 1
|
|
Psychiatric disorders
confusion
|
8.6%
3/35 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
congestion
|
5.7%
2/35 • Number of events 2
|
|
Infections and infestations
conjuctivitis
|
8.6%
3/35 • Number of events 5
|
|
Gastrointestinal disorders
constipation
|
65.7%
23/35 • Number of events 33
|
|
Skin and subcutaneous tissue disorders
contact dermatitis
|
2.9%
1/35 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
37.1%
13/35 • Number of events 17
|
|
Metabolism and nutrition disorders
high creatinine
|
20.0%
7/35 • Number of events 8
|
|
Gastrointestinal disorders
decreased appetite
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
dehydration
|
37.1%
13/35 • Number of events 17
|
|
Psychiatric disorders
dementia
|
2.9%
1/35 • Number of events 1
|
|
Psychiatric disorders
depression
|
22.9%
8/35 • Number of events 14
|
|
Blood and lymphatic system disorders
dermal changes
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
71.4%
25/35 • Number of events 51
|
|
General disorders
dizziness
|
34.3%
12/35 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
dry cough
|
2.9%
1/35 • Number of events 2
|
|
Eye disorders
dry eye
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
dry mouth
|
8.6%
3/35 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
dry skin
|
28.6%
10/35 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
37.1%
13/35 • Number of events 18
|
|
Gastrointestinal disorders
Dysgeusia
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
2/35 • Number of events 2
|
|
Gastrointestinal disorders
dysphagia
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
electrolyte imbalance
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
elevated LTF
|
2.9%
1/35 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
11.4%
4/35 • Number of events 5
|
|
Reproductive system and breast disorders
erectile dysfunction
|
5.7%
2/35 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
exostosis
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
eye infection
|
5.7%
2/35 • Number of events 3
|
|
Injury, poisoning and procedural complications
fall
|
2.9%
1/35 • Number of events 1
|
|
General disorders
fatigue
|
74.3%
26/35 • Number of events 39
|
|
Infections and infestations
febrile neutropenia
|
8.6%
3/35 • Number of events 3
|
|
General disorders
Fever
|
20.0%
7/35 • Number of events 11
|
|
Gastrointestinal disorders
flatulance
|
14.3%
5/35 • Number of events 5
|
|
Eye disorders
floater
|
2.9%
1/35 • Number of events 2
|
|
General disorders
flu-like symptoms
|
2.9%
1/35 • Number of events 1
|
|
Vascular disorders
Flush
|
2.9%
1/35 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
2.9%
1/35 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
fracture
|
5.7%
2/35 • Number of events 2
|
|
Infections and infestations
fungal infection
|
22.9%
8/35 • Number of events 9
|
|
General disorders
aches
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
hypergylcemia
|
77.1%
27/35 • Number of events 150
|
|
Gastrointestinal disorders
heartburn
|
11.4%
4/35 • Number of events 4
|
|
Renal and urinary disorders
hematuria
|
2.9%
1/35 • Number of events 1
|
|
Blood and lymphatic system disorders
anemia
|
91.4%
32/35 • Number of events 173
|
|
Hepatobiliary disorders
Hepatic Encephalopathy
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
herituism
|
2.9%
1/35 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
5.7%
2/35 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
hoarseness
|
2.9%
1/35 • Number of events 1
|
|
Vascular disorders
hot flashes
|
2.9%
1/35 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Hyperesthesia
|
2.9%
1/35 • Number of events 1
|
|
Vascular disorders
hypertension
|
14.3%
5/35 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
hypertochosis
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
hypokalemia
|
2.9%
1/35 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
62.9%
22/35 • Number of events 54
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
skin infection
|
14.3%
5/35 • Number of events 6
|
|
Infections and infestations
sinus infection
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
finger infection
|
2.9%
1/35 • Number of events 1
|
|
Psychiatric disorders
insomnia
|
34.3%
12/35 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
itching
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
IV infiltration
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
karatoses
|
2.9%
1/35 • Number of events 2
|
|
Renal and urinary disorders
kidney stone
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
toe infection
|
2.9%
1/35 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
leg cramps
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
leg ulceration
|
2.9%
1/35 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
65.7%
23/35 • Number of events 151
|
|
Nervous system disorders
light headedness
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
loss of appetite
|
8.6%
3/35 • Number of events 3
|
|
Investigations
lymphopenia
|
22.9%
8/35 • Number of events 79
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
5.7%
2/35 • Number of events 3
|
|
Gastrointestinal disorders
mouth sores
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
mucositis
|
25.7%
9/35 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
muscle cramping
|
5.7%
2/35 • Number of events 2
|
|
Gastrointestinal disorders
nausea
|
71.4%
25/35 • Number of events 35
|
|
Blood and lymphatic system disorders
neutropenic fever
|
8.6%
3/35 • Number of events 3
|
|
Investigations
Neutrophil count decreased
|
11.4%
4/35 • Number of events 6
|
|
General disorders
night sweats
|
11.4%
4/35 • Number of events 4
|
|
Nervous system disorders
numbness
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
oral thrush
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
occular infection
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
hypertrichosis
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
periorbital hair changes
|
5.7%
2/35 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
xerosis back
|
2.9%
1/35 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
buttock pain
|
2.9%
1/35 • Number of events 1
|
|
General disorders
chest pain
|
2.9%
1/35 • Number of events 2
|
|
Hepatobiliary disorders
Hepatic pain
|
2.9%
1/35 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
2.9%
1/35 • Number of events 1
|
|
Ear and labyrinth disorders
Ear Pain
|
2.9%
1/35 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
5.7%
2/35 • Number of events 3
|
|
Nervous system disorders
Solar Plexis Pain
|
2.9%
1/35 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
forearm pain
|
2.9%
1/35 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Upper Quadrant Pain
|
11.4%
4/35 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Scapula pain
|
2.9%
1/35 • Number of events 1
|
|
Injury, poisoning and procedural complications
stent pain
|
2.9%
1/35 • Number of events 1
|
|
Cardiac disorders
palpitations
|
11.4%
4/35 • Number of events 4
|
|
Infections and infestations
paronychia
|
5.7%
2/35 • Number of events 5
|
|
Vascular disorders
Pulmonary Embolism
|
11.4%
4/35 • Number of events 5
|
|
Cardiac disorders
Pericardial effusion
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
22.9%
8/35 • Number of events 20
|
|
Investigations
Platelet count decreased
|
71.4%
25/35 • Number of events 81
|
|
Reproductive system and breast disorders
Pleural effusion
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
pneumonia
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
poison ivy
|
2.9%
1/35 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
51.4%
18/35 • Number of events 58
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
2.9%
1/35 • Number of events 2
|
|
Investigations
Activated partial thromboplastin time prolonged
|
8.6%
3/35 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
rash
|
94.3%
33/35 • Number of events 135
|
|
Renal and urinary disorders
rectal bleeding
|
8.6%
3/35 • Number of events 3
|
|
Renal and urinary disorders
rectal fissure
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
reflux
|
2.9%
1/35 • Number of events 2
|
|
Renal and urinary disorders
renal failure
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
respiratory infection
|
2.9%
1/35 • Number of events 2
|
|
Immune system disorders
rhinitis
|
5.7%
2/35 • Number of events 2
|
|
General disorders
rigors
|
2.9%
1/35 • Number of events 1
|
|
Eye disorders
scratched cornea
|
2.9%
1/35 • Number of events 1
|
|
Immune system disorders
seasonal allergy
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
sepsis
|
8.6%
3/35 • Number of events 3
|
|
Infections and infestations
septic shock
|
2.9%
1/35 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
8.6%
3/35 • Number of events 4
|
|
Nervous system disorders
sinus headache
|
2.9%
1/35 • Number of events 1
|
|
Vascular disorders
sinus tachcardia
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
sinusitus
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
small bowel obstruction
|
5.7%
2/35 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.6%
3/35 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
65.7%
23/35 • Number of events 66
|
|
Nervous system disorders
somnolence
|
2.9%
1/35 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
11.4%
4/35 • Number of events 4
|
|
General disorders
sweating
|
8.6%
3/35 • Number of events 4
|
|
Nervous system disorders
syncope
|
5.7%
2/35 • Number of events 2
|
|
Gastrointestinal disorders
taste alteration
|
14.3%
5/35 • Number of events 5
|
|
Vascular disorders
deep vein thrombosis
|
5.7%
2/35 • Number of events 2
|
|
Blood and lymphatic system disorders
thrombocytosis
|
2.9%
1/35 • Number of events 1
|
|
Vascular disorders
thrombosis
|
5.7%
2/35 • Number of events 2
|
|
Infections and infestations
thrush
|
11.4%
4/35 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
trichomegaly
|
11.4%
4/35 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.9%
1/35 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory congestion
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
upset stomach
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
urinary tract infection
|
11.4%
4/35 • Number of events 5
|
|
Injury, poisoning and procedural complications
vessel injury
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
40.0%
14/35 • Number of events 24
|
|
Investigations
weight loss
|
28.6%
10/35 • Number of events 13
|
|
Infections and infestations
yeast infection
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.4%
4/35 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place