Trial Outcomes & Findings for Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma (NCT NCT00506142)
NCT ID: NCT00506142
Last Updated: 2019-12-11
Results Overview
Proportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
1 year
Results posted on
2019-12-11
Participant Flow
Participant milestones
| Measure |
Cohort 1
Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
|
Cohort 2
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
19
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
35
|
19
|
Reasons for withdrawal
| Measure |
Cohort 1
Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
|
Cohort 2
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
7
|
|
Overall Study
Lack of Efficacy
|
21
|
7
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
New health condition
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma
Baseline characteristics by cohort
| Measure |
Cohort 1
n=35 Participants
Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
|
Cohort 2
n=19 Participants
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week
Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 7.97 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 10.53 • n=5 Participants
|
|
Age, Customized
18-29 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
30-59 years
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Customized
>=60 years
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearProportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD)
Outcome measures
| Measure |
Cohort 1
n=35 Participants
Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
|
Cohort 2
n=19 Participants
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week
Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
|
|---|---|---|
|
Disease Control Rate
|
18 Participants
|
8 Participants
|
Adverse Events
Cohort 1
Serious events: 15 serious events
Other events: 35 other events
Deaths: 0 deaths
Cohort 2
Serious events: 9 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=35 participants at risk
Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
|
Cohort 2
n=19 participants at risk
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week
Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
|
|---|---|---|
|
Gastrointestinal disorders
ILEUS
|
5.7%
2/35 • Number of events 2 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
General disorders
DISEASE PROGRESSION
|
2.9%
1/35 • Number of events 1 • 5 years
|
10.5%
2/19 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.7%
2/35 • Number of events 2 • 5 years
|
10.5%
2/19 • Number of events 2 • 5 years
|
|
General disorders
DEATH
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.7%
2/35 • Number of events 2 • 5 years
|
0.00%
0/19 • 5 years
|
|
General disorders
PYREXIA
|
5.7%
2/35 • Number of events 2 • 5 years
|
0.00%
0/19 • 5 years
|
|
Injury, poisoning and procedural complications
VASCULAR ACCESS COMPLICATION
|
5.7%
2/35 • Number of events 3 • 5 years
|
0.00%
0/19 • 5 years
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
5.7%
2/35 • Number of events 2 • 5 years
|
0.00%
0/19 • 5 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
5.7%
2/35 • Number of events 2 • 5 years
|
0.00%
0/19 • 5 years
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
2.9%
1/35 • Number of events 2 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
2.9%
1/35 • Number of events 1 • 5 years
|
0.00%
0/19 • 5 years
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
2.9%
1/35 • Number of events 1 • 5 years
|
0.00%
0/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
2.9%
1/35 • Number of events 1 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Endocrine disorders
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
GASTRIC ILEUS
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
2.9%
1/35 • Number of events 1 • 5 years
|
0.00%
0/19 • 5 years
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
2.9%
1/35 • Number of events 1 • 5 years
|
0.00%
0/19 • 5 years
|
|
Gastrointestinal disorders
NAUSEA
|
2.9%
1/35 • Number of events 1 • 5 years
|
0.00%
0/19 • 5 years
|
|
Gastrointestinal disorders
VOMITING
|
2.9%
1/35 • Number of events 1 • 5 years
|
0.00%
0/19 • 5 years
|
|
General disorders
ASTHENIA
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
2.9%
1/35 • Number of events 1 • 5 years
|
0.00%
0/19 • 5 years
|
|
Infections and infestations
CENTRAL LINE INFECTION
|
2.9%
1/35 • Number of events 1 • 5 years
|
0.00%
0/19 • 5 years
|
|
Infections and infestations
KLEBSIELLA INFECTION
|
2.9%
1/35 • Number of events 1 • 5 years
|
0.00%
0/19 • 5 years
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.9%
1/35 • Number of events 1 • 5 years
|
0.00%
0/19 • 5 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.9%
1/35 • Number of events 1 • 5 years
|
0.00%
0/19 • 5 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.9%
1/35 • Number of events 1 • 5 years
|
0.00%
0/19 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC PAIN
|
2.9%
1/35 • Number of events 2 • 5 years
|
0.00%
0/19 • 5 years
|
|
Nervous system disorders
ENCEPHALOPATHY
|
2.9%
1/35 • Number of events 1 • 5 years
|
0.00%
0/19 • 5 years
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
2.9%
1/35 • Number of events 1 • 5 years
|
0.00%
0/19 • 5 years
|
Other adverse events
| Measure |
Cohort 1
n=35 participants at risk
Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
|
Cohort 2
n=19 participants at risk
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week
Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
25.7%
9/35 • Number of events 15 • 5 years
|
21.1%
4/19 • Number of events 9 • 5 years
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
2.9%
1/35 • Number of events 1 • 5 years
|
10.5%
2/19 • Number of events 2 • 5 years
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
5.7%
2/35 • Number of events 4 • 5 years
|
10.5%
2/19 • Number of events 3 • 5 years
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/35 • 5 years
|
10.5%
2/19 • Number of events 2 • 5 years
|
|
Ear and labyrinth disorders
EAR PAIN
|
8.6%
3/35 • Number of events 3 • 5 years
|
0.00%
0/19 • 5 years
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
5.7%
2/35 • Number of events 2 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/35 • 5 years
|
10.5%
2/19 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
8.6%
3/35 • Number of events 4 • 5 years
|
26.3%
5/19 • Number of events 5 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
25.7%
9/35 • Number of events 15 • 5 years
|
36.8%
7/19 • Number of events 7 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.7%
2/35 • Number of events 2 • 5 years
|
26.3%
5/19 • Number of events 5 • 5 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
71.4%
25/35 • Number of events 36 • 5 years
|
68.4%
13/19 • Number of events 17 • 5 years
|
|
Gastrointestinal disorders
DIARRHOEA
|
45.7%
16/35 • Number of events 22 • 5 years
|
26.3%
5/19 • Number of events 6 • 5 years
|
|
Gastrointestinal disorders
DRY MOUTH
|
2.9%
1/35 • Number of events 1 • 5 years
|
21.1%
4/19 • Number of events 4 • 5 years
|
|
Gastrointestinal disorders
DYSPEPSIA
|
14.3%
5/35 • Number of events 7 • 5 years
|
15.8%
3/19 • Number of events 3 • 5 years
|
|
Gastrointestinal disorders
FLATULENCE
|
5.7%
2/35 • Number of events 3 • 5 years
|
0.00%
0/19 • 5 years
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
5.7%
2/35 • Number of events 2 • 5 years
|
0.00%
0/19 • 5 years
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
NAUSEA
|
60.0%
21/35 • Number of events 39 • 5 years
|
52.6%
10/19 • Number of events 12 • 5 years
|
|
Gastrointestinal disorders
REGURGITATION
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
VOMITING
|
48.6%
17/35 • Number of events 29 • 5 years
|
47.4%
9/19 • Number of events 13 • 5 years
|
|
General disorders
ASTHENIA
|
5.7%
2/35 • Number of events 4 • 5 years
|
21.1%
4/19 • Number of events 5 • 5 years
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
General disorders
CHILLS
|
17.1%
6/35 • Number of events 11 • 5 years
|
15.8%
3/19 • Number of events 3 • 5 years
|
|
General disorders
FATIGUE
|
74.3%
26/35 • Number of events 38 • 5 years
|
73.7%
14/19 • Number of events 23 • 5 years
|
|
General disorders
FEELING OF BODY TEMPERATURE CHANGE
|
2.9%
1/35 • Number of events 1 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
General disorders
INFUSION SITE EXTRAVASATION
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
11.4%
4/35 • Number of events 4 • 5 years
|
5.3%
1/19 • Number of events 2 • 5 years
|
|
General disorders
OEDEMA
|
5.7%
2/35 • Number of events 2 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
General disorders
OEDEMA PERIPHERAL
|
8.6%
3/35 • Number of events 3 • 5 years
|
15.8%
3/19 • Number of events 4 • 5 years
|
|
General disorders
PAIN
|
34.3%
12/35 • Number of events 13 • 5 years
|
21.1%
4/19 • Number of events 5 • 5 years
|
|
General disorders
PYREXIA
|
45.7%
16/35 • Number of events 30 • 5 years
|
26.3%
5/19 • Number of events 7 • 5 years
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
11.4%
4/35 • Number of events 8 • 5 years
|
10.5%
2/19 • Number of events 4 • 5 years
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Infections and infestations
BRONCHITIS
|
8.6%
3/35 • Number of events 3 • 5 years
|
0.00%
0/19 • 5 years
|
|
Infections and infestations
FUNGAL INFECTION
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Infections and infestations
SKIN CANDIDA
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.9%
1/35 • Number of events 1 • 5 years
|
10.5%
2/19 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/35 • 5 years
|
21.1%
4/19 • Number of events 15 • 5 years
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/35 • 5 years
|
31.6%
6/19 • Number of events 16 • 5 years
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
8.6%
3/35 • Number of events 8 • 5 years
|
15.8%
3/19 • Number of events 6 • 5 years
|
|
Investigations
BLOOD CHLORIDE DECREASED
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
11.4%
4/35 • Number of events 4 • 5 years
|
0.00%
0/19 • 5 years
|
|
Investigations
HAEMOGLOBIN DECREASED
|
2.9%
1/35 • Number of events 1 • 5 years
|
10.5%
2/19 • Number of events 4 • 5 years
|
|
Investigations
WEIGHT DECREASED
|
20.0%
7/35 • Number of events 8 • 5 years
|
10.5%
2/19 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
62.9%
22/35 • Number of events 29 • 5 years
|
52.6%
10/19 • Number of events 10 • 5 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
5.7%
2/35 • Number of events 2 • 5 years
|
10.5%
2/19 • Number of events 3 • 5 years
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 3 • 5 years
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
5.7%
2/35 • Number of events 3 • 5 years
|
5.3%
1/19 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
2.9%
1/35 • Number of events 1 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
5.7%
2/35 • Number of events 2 • 5 years
|
0.00%
0/19 • 5 years
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
20.0%
7/35 • Number of events 12 • 5 years
|
31.6%
6/19 • Number of events 10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
22.9%
8/35 • Number of events 14 • 5 years
|
26.3%
5/19 • Number of events 12 • 5 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
14.3%
5/35 • Number of events 6 • 5 years
|
21.1%
4/19 • Number of events 4 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
2.9%
1/35 • Number of events 1 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
5.7%
2/35 • Number of events 2 • 5 years
|
21.1%
4/19 • Number of events 4 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
2.9%
1/35 • Number of events 1 • 5 years
|
10.5%
2/19 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
5.7%
2/35 • Number of events 3 • 5 years
|
10.5%
2/19 • Number of events 3 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
17.1%
6/35 • Number of events 9 • 5 years
|
26.3%
5/19 • Number of events 12 • 5 years
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
5.7%
2/35 • Number of events 2 • 5 years
|
0.00%
0/19 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
28.6%
10/35 • Number of events 14 • 5 years
|
10.5%
2/19 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
5.7%
2/35 • Number of events 2 • 5 years
|
21.1%
4/19 • Number of events 4 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
5.7%
2/35 • Number of events 2 • 5 years
|
0.00%
0/19 • 5 years
|
|
Nervous system disorders
DIZZINESS
|
5.7%
2/35 • Number of events 2 • 5 years
|
15.8%
3/19 • Number of events 3 • 5 years
|
|
Nervous system disorders
DYSARTHRIA
|
11.4%
4/35 • Number of events 4 • 5 years
|
0.00%
0/19 • 5 years
|
|
Nervous system disorders
DYSGEUSIA
|
11.4%
4/35 • Number of events 4 • 5 years
|
0.00%
0/19 • 5 years
|
|
Nervous system disorders
HEADACHE
|
37.1%
13/35 • Number of events 14 • 5 years
|
31.6%
6/19 • Number of events 9 • 5 years
|
|
Nervous system disorders
HYPERAESTHESIA
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/35 • 5 years
|
15.8%
3/19 • Number of events 4 • 5 years
|
|
Nervous system disorders
HYPOREFLEXIA
|
0.00%
0/35 • 5 years
|
26.3%
5/19 • Number of events 10 • 5 years
|
|
Nervous system disorders
NEURALGIA
|
2.9%
1/35 • Number of events 1 • 5 years
|
5.3%
1/19 • Number of events 3 • 5 years
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
42.9%
15/35 • Number of events 28 • 5 years
|
5.3%
1/19 • Number of events 3 • 5 years
|
|
Nervous system disorders
PARAESTHESIA
|
22.9%
8/35 • Number of events 13 • 5 years
|
47.4%
9/19 • Number of events 19 • 5 years
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
22.9%
8/35 • Number of events 17 • 5 years
|
26.3%
5/19 • Number of events 8 • 5 years
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
31.4%
11/35 • Number of events 19 • 5 years
|
47.4%
9/19 • Number of events 23 • 5 years
|
|
Psychiatric disorders
ANXIETY
|
8.6%
3/35 • Number of events 4 • 5 years
|
10.5%
2/19 • Number of events 4 • 5 years
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Psychiatric disorders
DEPRESSION
|
5.7%
2/35 • Number of events 3 • 5 years
|
0.00%
0/19 • 5 years
|
|
Psychiatric disorders
INSOMNIA
|
25.7%
9/35 • Number of events 10 • 5 years
|
31.6%
6/19 • Number of events 6 • 5 years
|
|
Psychiatric disorders
MOOD ALTERED
|
2.9%
1/35 • Number of events 1 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
HAEMATURIA
|
5.7%
2/35 • Number of events 2 • 5 years
|
0.00%
0/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.7%
2/35 • Number of events 2 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
8.6%
3/35 • Number of events 3 • 5 years
|
10.5%
2/19 • Number of events 4 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
37.1%
13/35 • Number of events 18 • 5 years
|
21.1%
4/19 • Number of events 6 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
5.7%
2/35 • Number of events 2 • 5 years
|
0.00%
0/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
14.3%
5/35 • Number of events 5 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PAINFUL RESPIRATION
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
VOCAL CORD ATROPHY
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
42.9%
15/35 • Number of events 15 • 5 years
|
5.3%
1/19 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
COLD SWEAT
|
2.9%
1/35 • Number of events 1 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 3 • 5 years
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/35 • 5 years
|
10.5%
2/19 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
5.7%
2/35 • Number of events 2 • 5 years
|
0.00%
0/19 • 5 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
28.6%
10/35 • Number of events 12 • 5 years
|
5.3%
1/19 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
RASH
|
25.7%
9/35 • Number of events 15 • 5 years
|
10.5%
2/19 • Number of events 4 • 5 years
|
|
Vascular disorders
HOT FLUSH
|
8.6%
3/35 • Number of events 3 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
|
Vascular disorders
HYPERTENSION
|
5.7%
2/35 • Number of events 2 • 5 years
|
10.5%
2/19 • Number of events 2 • 5 years
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/35 • 5 years
|
10.5%
2/19 • Number of events 2 • 5 years
|
|
Vascular disorders
VASOCONSTRICTION
|
0.00%
0/35 • 5 years
|
5.3%
1/19 • Number of events 1 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place