Trial Outcomes & Findings for A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas (NCT NCT00995007)
NCT ID: NCT00995007
Last Updated: 2016-03-29
Results Overview
Percentage of participants who are alive and progression-free at 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
112 participants
Primary outcome timeframe
6 months
Results posted on
2016-03-29
Participant Flow
Participant milestones
| Measure |
Carboplatin
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Vandetanib With Carboplatin
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
|
Overall Study
Crossover to Vandetanib
|
42
|
0
|
|
Overall Study
COMPLETED
|
39
|
54
|
|
Overall Study
NOT COMPLETED
|
17
|
2
|
Reasons for withdrawal
| Measure |
Carboplatin
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Vandetanib With Carboplatin
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
|---|---|---|
|
Overall Study
Withdrew consent
|
1
|
0
|
|
Overall Study
Refused further treatment
|
8
|
2
|
|
Overall Study
Toxicity
|
8
|
0
|
Baseline Characteristics
A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas
Baseline characteristics by cohort
| Measure |
Carboplatin
n=56 Participants
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Vandetanib With Carboplatin
n=56 Participants
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
105 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Age, Continuous
|
50.29 years
STANDARD_DEVIATION 13.29 • n=93 Participants
|
50.10 years
STANDARD_DEVIATION 12.43 • n=4 Participants
|
50.13 years
STANDARD_DEVIATION 12.81 • n=27 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
111 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
105 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=93 Participants
|
56 participants
n=4 Participants
|
112 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The group data is displayed per the report provided to the Food and Drug Administration.
Percentage of participants who are alive and progression-free at 6 months.
Outcome measures
| Measure |
Glioblastoma (Combination)
n=33 Participants
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Glioblastoma (Carboplatin Alone)
n=33 Participants
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Anaplastic Astrocytomas (Combination)
n=23 Participants
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Anaplastic Astrocytomas (Carboplatin Alone)
n=23 Participants
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
|---|---|---|---|---|
|
Progression Free Survival at 6 Months
|
1.71 percentage of participants
|
0.89 percentage of participants
|
8.7 percentage of participants
|
17.4 percentage of participants
|
SECONDARY outcome
Timeframe: Time between the first day of treatment and the day of death, up to 1.5 yearsPopulation: The group data is displayed per the report provided to the Food and Drug Administration.
Time between the first day of treatment and the day of death.
Outcome measures
| Measure |
Glioblastoma (Combination)
n=33 Participants
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Glioblastoma (Carboplatin Alone)
n=33 Participants
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Anaplastic Astrocytomas (Combination)
n=23 Participants
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Anaplastic Astrocytomas (Carboplatin Alone)
n=23 Participants
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
|---|---|---|---|---|
|
Overall Survival
|
5.58 Months
Interval 4.6 to 8.65
|
5.22 Months
Interval 3.78 to 7.46
|
6.5 Months
Interval 5.42 to 11.7
|
9.27 Months
Interval 5.52 to 43.86
|
SECONDARY outcome
Timeframe: 70 months and 19 daysHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Glioblastoma (Combination)
n=56 Participants
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Glioblastoma (Carboplatin Alone)
n=56 Participants
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Anaplastic Astrocytomas (Combination)
n=42 Participants
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Anaplastic Astrocytomas (Carboplatin Alone)
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
55 participants
|
56 participants
|
40 participants
|
—
|
Adverse Events
Carboplatin
Serious events: 10 serious events
Other events: 55 other events
Deaths: 0 deaths
Vandetanib With Carboplatin
Serious events: 21 serious events
Other events: 56 other events
Deaths: 0 deaths
Crossover to Vandetanib
Serious events: 13 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carboplatin
n=56 participants at risk
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Vandetanib With Carboplatin
n=56 participants at risk
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Crossover to Vandetanib
n=42 participants at risk
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
|
|---|---|---|---|
|
General disorders
Death Not otherwise specified (NOS)
|
1.8%
1/56 • Number of events 1
|
3.6%
2/56 • Number of events 2
|
14.3%
6/42 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
1.8%
1/56 • Number of events 4
|
0.00%
0/56
|
0.00%
0/42
|
|
Nervous system disorders
Hydrocephalus
|
1.8%
1/56 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.6%
2/56 • Number of events 2
|
1.8%
1/56 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Infections and infestations
Periorbital infection
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Investigations
Platelet count decreased
|
3.6%
2/56 • Number of events 3
|
3.6%
2/56 • Number of events 3
|
0.00%
0/42
|
|
Nervous system disorders
Pyramidal tract syndrome
|
3.6%
2/56 • Number of events 2
|
0.00%
0/56
|
0.00%
0/42
|
|
Cardiac disorders
Sinus tachycardia
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Vascular disorders
Thromboembolic event
|
1.8%
1/56 • Number of events 1
|
5.4%
3/56 • Number of events 3
|
0.00%
0/42
|
|
Nervous system disorders
Ataxia
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Infections and infestations - Other, specify (UTI)
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Seizure
|
0.00%
0/56
|
7.1%
4/56 • Number of events 4
|
11.9%
5/42 • Number of events 5
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
General disorders
Fever
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Vascular disorders
Hematoma
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Infections and infestations - Other, specify (cellulitis)
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Lung infection
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/56
|
3.6%
2/56 • Number of events 2
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
Other adverse events
| Measure |
Carboplatin
n=56 participants at risk
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Vandetanib With Carboplatin
n=56 participants at risk
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
|
Crossover to Vandetanib
n=42 participants at risk
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
|
|---|---|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
3.6%
2/56 • Number of events 2
|
8.9%
5/56 • Number of events 11
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
33.9%
19/56 • Number of events 29
|
76.8%
43/56 • Number of events 74
|
57.1%
24/42 • Number of events 29
|
|
Investigations
Alkaline phosphatase increased
|
7.1%
4/56 • Number of events 4
|
30.4%
17/56 • Number of events 20
|
14.3%
6/42 • Number of events 6
|
|
Blood and lymphatic system disorders
Anemia
|
53.6%
30/56 • Number of events 67
|
46.4%
26/56 • Number of events 74
|
9.5%
4/42 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
5.4%
3/56 • Number of events 3
|
50.0%
28/56 • Number of events 44
|
33.3%
14/42 • Number of events 17
|
|
Investigations
Blood bilirubin increased
|
3.6%
2/56 • Number of events 2
|
14.3%
8/56 • Number of events 11
|
7.1%
3/42 • Number of events 3
|
|
Cardiac disorders
Cardiac disorders - Other, specify (Qtc prolonged)
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Hepatobiliary disorders
Cholecystitis
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Investigations
Cholesterol high
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Nervous system disorders
Cognitive disturbance
|
1.8%
1/56 • Number of events 2
|
0.00%
0/56
|
7.1%
3/42 • Number of events 3
|
|
Nervous system disorders
Concentration impairment
|
1.8%
1/56 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Nervous system disorders
Confusion
|
1.8%
1/56 • Number of events 1
|
5.4%
3/56 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
3.6%
2/56 • Number of events 3
|
7.1%
4/56 • Number of events 4
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Creatinine increased
|
1.8%
1/56 • Number of events 1
|
35.7%
20/56 • Number of events 40
|
28.6%
12/42 • Number of events 13
|
|
Endocrine disorders
Cushingoid
|
3.6%
2/56 • Number of events 2
|
0.00%
0/56
|
0.00%
0/42
|
|
Nervous system disorders
Depressed level of consciousness
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Psychiatric disorders
Depression
|
3.6%
2/56 • Number of events 2
|
8.9%
5/56 • Number of events 6
|
4.8%
2/42 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
3.6%
2/56 • Number of events 2
|
5.4%
3/56 • Number of events 3
|
0.00%
0/42
|
|
Eye disorders
Dry eye
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Nervous system disorders
Dysesthesia
|
1.8%
1/56 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Nervous system disorders
Dysphasia
|
7.1%
4/56 • Number of events 4
|
5.4%
3/56 • Number of events 3
|
4.8%
2/42 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
1/56 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Ear and labyrinth disorders
Ear pain
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
5.4%
3/56 • Number of events 5
|
39.3%
22/56 • Number of events 38
|
42.9%
18/42 • Number of events 27
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.6%
2/56 • Number of events 2
|
7.1%
4/56 • Number of events 5
|
2.4%
1/42 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Eye disorders
Eye disorders - Other, specify (diplopia)
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Eye disorders
Eye disorders - Other, specify (Stye)
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
General disorders
Fatigue
|
28.6%
16/56 • Number of events 29
|
33.9%
19/56 • Number of events 24
|
7.1%
3/42 • Number of events 3
|
|
Gastrointestinal disorders
Fecal incontinence
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
General disorders
Flu like symptoms
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
General disorders
Gait disturbance
|
1.8%
1/56 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify (cholelithiasis)
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Vascular disorders
Hot flashes
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Infections and infestations
Infections and infestations - Other, specify (sore throat)
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
General disorders
Infusion related reaction
|
3.6%
2/56 • Number of events 3
|
0.00%
0/56
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
General disorders
Lethargy
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Nervous system disorders
Nervous system disorders - Other, specify (visual field deficit)
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Nervous system disorders
Oculomotor nerve disorder
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Nervous system disorders
Paresthesia
|
1.8%
1/56 • Number of events 2
|
0.00%
0/56
|
0.00%
0/42
|
|
Nervous system disorders
Presyncope
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Nervous system disorders
Psychosis
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Nervous system disorders
Pyramidal tract syndrome
|
7.1%
4/56 • Number of events 5
|
3.6%
2/56 • Number of events 3
|
2.4%
1/42 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.6%
2/56 • Number of events 2
|
62.5%
35/56 • Number of events 45
|
57.1%
24/42 • Number of events 27
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Rhinitis infective
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Infections and infestations
Salivary gland infection
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Nervous system disorders
Seizure
|
12.5%
7/56 • Number of events 9
|
25.0%
14/56 • Number of events 33
|
9.5%
4/42 • Number of events 4
|
|
Cardiac disorders
Sinus bradycardia
|
5.4%
3/56 • Number of events 4
|
7.1%
4/56 • Number of events 4
|
11.9%
5/42 • Number of events 7
|
|
Infections and infestations
Skin infection
|
1.8%
1/56 • Number of events 1
|
5.4%
3/56 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
|
Vascular disorders
Superficial thrombophlebitis
|
1.8%
1/56 • Number of events 2
|
0.00%
0/56
|
0.00%
0/42
|
|
Nervous system disorders
Syncope
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Infections and infestations
Upper respiratory infection
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
7.1%
3/42 • Number of events 3
|
|
Renal and urinary disorders
Urinary incontinence
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
4/56 • Number of events 4
|
7.1%
4/56 • Number of events 6
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Weight loss
|
3.6%
2/56 • Number of events 2
|
10.7%
6/56 • Number of events 7
|
4.8%
2/42 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
0.00%
0/42
|
|
Investigations
White blood cell decreased
|
58.9%
33/56 • Number of events 108
|
51.8%
29/56 • Number of events 96
|
33.3%
14/42 • Number of events 17
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Acoustic nerve disorder Not otherwise specified (NOS)
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/56
|
3.6%
2/56 • Number of events 4
|
2.4%
1/42 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
3.6%
2/56 • Number of events 2
|
3.6%
2/56 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
1.8%
1/56 • Number of events 1
|
5.4%
3/56 • Number of events 3
|
9.5%
4/42 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/56 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.00%
0/56
|
5.4%
3/56 • Number of events 4
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/56 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Eye disorders
Blurred vision
|
3.6%
2/56 • Number of events 2
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Investigations
CPK increased
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Vascular disorders
Flushing
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Hemoglobin increased
|
0.00%
0/56
|
5.4%
3/56 • Number of events 5
|
9.5%
4/42 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.8%
1/56 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.7%
6/56 • Number of events 6
|
5.4%
3/56 • Number of events 4
|
11.9%
5/42 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/56
|
8.9%
5/56 • Number of events 7
|
9.5%
4/42 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
8.9%
5/56 • Number of events 5
|
16.1%
9/56 • Number of events 11
|
7.1%
3/42 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.4%
3/56 • Number of events 3
|
10.7%
6/56 • Number of events 15
|
4.8%
2/42 • Number of events 2
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.8%
1/56 • Number of events 1
|
21.4%
12/56 • Number of events 23
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
4/56 • Number of events 7
|
26.8%
15/56 • Number of events 19
|
9.5%
4/42 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/56
|
3.6%
2/56 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.8%
1/56 • Number of events 1
|
7.1%
4/56 • Number of events 8
|
7.1%
3/42 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
7/56 • Number of events 9
|
30.4%
17/56 • Number of events 44
|
4.8%
2/42 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.9%
5/56 • Number of events 7
|
19.6%
11/56 • Number of events 14
|
11.9%
5/42 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.9%
19/56 • Number of events 25
|
33.9%
19/56 • Number of events 34
|
26.2%
11/42 • Number of events 12
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Infections and infestations - Other, specify (vaginal candidiasis)
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify (left shoulder fracture)
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Insomnia
|
0.00%
0/56
|
0.00%
0/56
|
4.8%
2/42 • Number of events 2
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Localized edema
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Vascular disorders
Lymphedema
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
69.6%
39/56 • Number of events 122
|
78.6%
44/56 • Number of events 122
|
64.3%
27/42 • Number of events 44
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
1.8%
1/56 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
|
Infections and infestations
Mucosal infection
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/56
|
7.1%
4/56 • Number of events 4
|
9.5%
4/42 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.6%
2/56 • Number of events 2
|
5.4%
3/56 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
3.6%
2/56 • Number of events 2
|
5.4%
3/56 • Number of events 4
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
12.5%
7/56 • Number of events 11
|
16.1%
9/56 • Number of events 11
|
7.1%
3/42 • Number of events 4
|
|
Investigations
Neutrophil count decreased
|
32.1%
18/56 • Number of events 59
|
26.8%
15/56 • Number of events 48
|
11.9%
5/42 • Number of events 6
|
|
Eye disorders
Optic nerve disorder
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Pain
|
3.6%
2/56 • Number of events 2
|
3.6%
2/56 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/56 • Number of events 1
|
5.4%
3/56 • Number of events 5
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/56
|
3.6%
2/56 • Number of events 4
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/56
|
0.00%
0/56
|
4.8%
2/42 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/56
|
12.5%
7/56 • Number of events 10
|
14.3%
6/42 • Number of events 6
|
|
Investigations
Platelet count decreased
|
85.7%
48/56 • Number of events 119
|
91.1%
51/56 • Number of events 129
|
40.5%
17/42 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 2
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify (erythema)
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.6%
2/56 • Number of events 2
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/56
|
3.6%
2/56 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.00%
0/56
|
3.6%
2/56 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/56
|
0.00%
0/56
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/56
|
3.6%
2/56 • Number of events 2
|
0.00%
0/42
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Breast infection
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/56 • Number of events 1
|
3.6%
2/56 • Number of events 2
|
0.00%
0/42
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/56
|
51.8%
29/56 • Number of events 46
|
0.00%
0/42
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
General disorders
Edema limbs
|
0.00%
0/56
|
3.6%
2/56 • Number of events 3
|
0.00%
0/42
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
General disorders
Fever
|
0.00%
0/56
|
1.8%
1/56 • Number of events 2
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.6%
2/56 • Number of events 2
|
7.1%
4/56 • Number of events 6
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Headache
|
14.3%
8/56 • Number of events 10
|
8.9%
5/56 • Number of events 6
|
9.5%
4/42 • Number of events 6
|
|
Cardiac disorders
Heart failure
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/56
|
3.6%
2/56 • Number of events 3
|
0.00%
0/42
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/56
|
3.6%
2/56 • Number of events 2
|
0.00%
0/42
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.6%
2/56 • Number of events 3
|
5.4%
3/56 • Number of events 3
|
7.1%
3/42 • Number of events 3
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Vascular disorders
Hypertension
|
0.00%
0/56
|
41.1%
23/56 • Number of events 35
|
28.6%
12/42 • Number of events 14
|
|
Vascular disorders
Hypotension
|
1.8%
1/56 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Investigations
INR increased
|
0.00%
0/56
|
1.8%
1/56 • Number of events 2
|
0.00%
0/42
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/56
|
3.6%
2/56 • Number of events 2
|
0.00%
0/42
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/56
|
7.1%
4/56 • Number of events 5
|
0.00%
0/42
|
|
Investigations
Investigations - Other, specify (elevated LDH)
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
General disorders
Irritability
|
0.00%
0/56
|
1.8%
1/56 • Number of events 2
|
0.00%
0/42
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Lung infection
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.8%
1/56 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Paronychia
|
0.00%
0/56
|
3.6%
2/56 • Number of events 2
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/56
|
1.8%
1/56 • Number of events 2
|
0.00%
0/42
|
|
Renal and urinary disorders
Proteinuria
|
1.8%
1/56 • Number of events 1
|
8.9%
5/56 • Number of events 8
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/56
|
5.4%
3/56 • Number of events 3
|
0.00%
0/42
|
|
Infections and infestations
Sinusitis
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify (paronychia)
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Tooth infection
|
0.00%
0/56
|
1.8%
1/56 • Number of events 2
|
0.00%
0/42
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/56
|
1.8%
1/56 • Number of events 1
|
0.00%
0/42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place