Trial Outcomes & Findings for Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer (NCT NCT00753675)
NCT ID: NCT00753675
Last Updated: 2016-10-10
Results Overview
Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
174 participants
Primary outcome timeframe
up to 1032 days
Results posted on
2016-10-10
Participant Flow
180 subjects were screened at 19 sites and 174 were randomized
Participant milestones
| Measure |
Arm A Vandetanib 300 mg
Vandetanib 300 mg as a once daily oral dose, from Day 1
|
Arm B Vandetanib 100mg + Gemcitab
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
|
ARM C Placebo+ Gemcitabine
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
|
|---|---|---|---|
|
Overall Study
STARTED
|
59
|
59
|
56
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
59
|
59
|
56
|
Reasons for withdrawal
| Measure |
Arm A Vandetanib 300 mg
Vandetanib 300 mg as a once daily oral dose, from Day 1
|
Arm B Vandetanib 100mg + Gemcitab
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
|
ARM C Placebo+ Gemcitabine
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
|
|---|---|---|---|
|
Overall Study
other reason
|
11
|
12
|
13
|
|
Overall Study
Death
|
1
|
2
|
4
|
|
Overall Study
Adverse Event
|
11
|
9
|
4
|
|
Overall Study
Objective progression of disease
|
35
|
35
|
35
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer
Baseline characteristics by cohort
| Measure |
Arm A Vandetanib 300 mg
n=59 Participants
Vandetanib 300 mg as a once daily oral dose, from Day 1
|
Arm B Vandetanib 100mg + Gemcitab
n=58 Participants
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
|
ARM C Placebo+ Gemcitabine
n=56 Participants
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.39 years
STANDARD_DEVIATION 10.108 • n=5 Participants
|
64.41 years
STANDARD_DEVIATION 9.455 • n=7 Participants
|
63.95 years
STANDARD_DEVIATION 8.764 • n=5 Participants
|
63.57 years
STANDARD_DEVIATION 9.456 • n=4 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 1032 daysPopulation: ITT
Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).
Outcome measures
| Measure |
Arm A Vandetanib 300 mg
n=56 Participants
Vandetanib 300 mg as a once daily oral dose, from Day 1
|
Arm B Vandetanib 100mg + Gemcitab
n=57 Participants
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
|
ARM C Placebo+ Gemcitabine
n=52 Participants
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
|
|---|---|---|---|
|
Progression Free Survival
|
105 days
Interval 72.0 to 155.0
|
114 days
Interval 91.0 to 193.0
|
148 days
Interval 72.0 to 225.0
|
SECONDARY outcome
Timeframe: up to 1032 daysPopulation: ITT
Objective Tumor Response Rate was defined as complete response (CR) + partial response (PR) evaluated by RECIST. CR was defined as disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of longest diameters (LD) of target lesion(s) taking as reference the baseline sum of LD
Outcome measures
| Measure |
Arm A Vandetanib 300 mg
n=56 Participants
Vandetanib 300 mg as a once daily oral dose, from Day 1
|
Arm B Vandetanib 100mg + Gemcitab
n=57 Participants
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
|
ARM C Placebo+ Gemcitabine
n=52 Participants
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
|
|---|---|---|---|
|
Objective Tumor Response Rate (CR+PR),
Objective Response = NO
|
54 Participants
|
46 Participants
|
45 Participants
|
|
Objective Tumor Response Rate (CR+PR),
Objective Response = YES
|
2 Participants
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: up to 1032 daysPopulation: ITT
DCR is the sum of patients with a best overall CR, PR or SD (\>=8 weeks) by the patient in the analysis
Outcome measures
| Measure |
Arm A Vandetanib 300 mg
n=56 Participants
Vandetanib 300 mg as a once daily oral dose, from Day 1
|
Arm B Vandetanib 100mg + Gemcitab
n=57 Participants
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
|
ARM C Placebo+ Gemcitabine
n=52 Participants
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
|
|---|---|---|---|
|
Disease Control Rate (CR+PR+SD)
Disease control rate = NO
|
42 Partecipants
|
40 Partecipants
|
32 Partecipants
|
|
Disease Control Rate (CR+PR+SD)
Disease control rate = YES
|
14 Partecipants
|
17 Partecipants
|
20 Partecipants
|
SECONDARY outcome
Timeframe: up to 1032 daysPopulation: ITT (best response of CR or PR only)
DOR is defined from the date of first documentation of response until date of PD or death
Outcome measures
| Measure |
Arm A Vandetanib 300 mg
n=2 Participants
Vandetanib 300 mg as a once daily oral dose, from Day 1
|
Arm B Vandetanib 100mg + Gemcitab
n=11 Participants
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
|
ARM C Placebo+ Gemcitabine
n=7 Participants
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
|
|---|---|---|---|
|
Duration of Response (DOR)
|
277 Days
Interval 267.0 to 286.0
|
179 Days
Interval 85.0 to 369.0
|
127 Days
Interval 85.0 to 152.0
|
SECONDARY outcome
Timeframe: up to 1032 daysPopulation: ITT
OS is defined from the date of randomization to death
Outcome measures
| Measure |
Arm A Vandetanib 300 mg
n=56 Participants
Vandetanib 300 mg as a once daily oral dose, from Day 1
|
Arm B Vandetanib 100mg + Gemcitab
n=57 Participants
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
|
ARM C Placebo+ Gemcitabine
n=52 Participants
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
|
|---|---|---|---|
|
Overall Survival
|
228 Days
Interval 190.0 to 364.0
|
284 Days
Interval 213.0 to 359.0
|
307 Days
Interval 254.0 to 523.0
|
Adverse Events
Arm A Vandetanib 300 mg
Serious events: 16 serious events
Other events: 57 other events
Deaths: 0 deaths
Arm B Vandetanib 100mg + Gemcitab
Serious events: 15 serious events
Other events: 53 other events
Deaths: 0 deaths
ARM C Placebo+ Gemcitabine
Serious events: 12 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A Vandetanib 300 mg
n=59 participants at risk
Vandetanib 300 mg as a once daily oral dose, from Day 1
|
Arm B Vandetanib 100mg + Gemcitab
n=58 participants at risk
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
|
ARM C Placebo+ Gemcitabine
n=56 participants at risk
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Disseminated Intravascular
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
General disorders
Asthenia
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Hepatobiliary disorders
Acute Hepatic Failure
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Investigations
Blood Bilirubin
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Epilepsy
|
3.4%
2/59 • Number of events 2
|
—
0/0
|
—
0/0
|
|
Renal and urinary disorders
Oliguria
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/59 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
0.00%
0/56
|
|
Vascular disorders
Hypertension
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Cardiac disorders
Torsade de Pointes
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Gastrointestinal disorders
Ascites
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
3/59 • Number of events 3
|
0.00%
0/58
|
3.6%
2/56 • Number of events 2
|
|
General disorders
Condition Aggravated
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Fatigue
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
General disorders
General Physical Health Deterioration
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
General disorders
Pyrexia
|
5.1%
3/59 • Number of events 3
|
0.00%
0/58
|
3.6%
2/56 • Number of events 2
|
|
Hepatobiliary disorders
Cholangites
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubineamia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/59
|
3.4%
2/58 • Number of events 2
|
3.6%
2/56 • Number of events 2
|
|
Investigations
Blood Bilirubin increased
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Investigations
Electrocardiogram Repolarisation Abnormaly
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/59
|
3.4%
2/58 • Number of events 2
|
1.8%
1/56 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/59
|
3.4%
2/58 • Number of events 2
|
0.00%
0/56
|
|
Vascular disorders
Hypotension
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
Other adverse events
| Measure |
Arm A Vandetanib 300 mg
n=59 participants at risk
Vandetanib 300 mg as a once daily oral dose, from Day 1
|
Arm B Vandetanib 100mg + Gemcitab
n=58 participants at risk
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
|
ARM C Placebo+ Gemcitabine
n=56 participants at risk
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
1/59 • Number of events 4
|
17.2%
10/58 • Number of events 20
|
12.5%
7/56 • Number of events 18
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
3.6%
2/56 • Number of events 3
|
|
General disorders
Asthenia
|
11.9%
7/59 • Number of events 7
|
24.1%
14/58 • Number of events 17
|
26.8%
15/56 • Number of events 20
|
|
Hepatobiliary disorders
Acute Hepatic Failure
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Bacterial Rhinitis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Investigations
Alanine aminotransferase
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
8.9%
5/56 • Number of events 5
|
|
Nervous system disorders
Agitated Depression
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Renal and urinary disorders
Bladder hypertrophy
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
3.6%
2/56 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Vascular disorders
Deep Vein thrombosis
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia macrocytic
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Blood and lymphatic system disorders
Autoimmune thrombocytopenia
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Blood and lymphatic system disorders
Dessemintaed Intracascula Coagulation
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Blood and lymphatic system disorders
Hyperbilirubineamia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 2
|
0.00%
0/56
|
|
Blood and lymphatic system disorders
Iron deficency anemia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Blood and lymphatic system disorders
Leukcytosis
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/59
|
5.2%
3/58 • Number of events 6
|
10.7%
6/56 • Number of events 17
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Blood and lymphatic system disorders
Platelet production decreased
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
2/59 • Number of events 2
|
8.6%
5/58 • Number of events 7
|
3.6%
2/56 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
Blood and lymphatic system disorders
White blood cell disorder
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/59
|
12.1%
7/58 • Number of events 15
|
17.9%
10/56 • Number of events 28
|
|
Cardiac disorders
Arrhytmia
|
1.7%
1/59 • Number of events 2
|
0.00%
0/58
|
0.00%
0/56
|
|
Cardiac disorders
Atrial Fibrillation
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 2
|
1.8%
1/56 • Number of events 1
|
|
Cardiac disorders
Bundle branch block
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Cardiac disorders
Bundle Branch block right
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Cardiac disorders
Oedema peripheral
|
0.00%
0/59
|
3.4%
2/58 • Number of events 2
|
0.00%
0/56
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Cardiac disorders
Tachycardia
|
3.4%
2/59 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Cardiac disorders
Torsade de pointes
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Endocrine disorders
Diabete Mellitus
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Endocrine disorders
Hyperglycamia
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Eye disorders
Conjunctival hemorrhage
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Eye disorders
Eye pruritus
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Eye disorders
Ocular icterus
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Eye disorders
Periorbital Oedema
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
25.4%
15/59 • Number of events 16
|
13.8%
8/58 • Number of events 9
|
25.0%
14/56 • Number of events 17
|
|
Gastrointestinal disorders
Abdominal Pain upper
|
5.1%
3/59 • Number of events 3
|
10.3%
6/58 • Number of events 6
|
10.7%
6/56 • Number of events 6
|
|
Gastrointestinal disorders
Aborectal discomfort
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
6.8%
4/59 • Number of events 4
|
3.4%
2/58 • Number of events 2
|
3.6%
2/56 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
3.4%
2/59 • Number of events 2
|
5.2%
3/58 • Number of events 3
|
16.1%
9/56 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhoea
|
25.4%
15/59 • Number of events 32
|
10.3%
6/58 • Number of events 13
|
14.3%
8/56 • Number of events 10
|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
2/59 • Number of events 2
|
0.00%
0/58
|
0.00%
0/56
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Gastrointestinal disorders
Dysgeusia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
3.6%
2/56 • Number of events 4
|
|
Gastrointestinal disorders
Dyshagia
|
1.7%
1/59 • Number of events 2
|
0.00%
0/58
|
0.00%
0/56
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Gastrointestinal disorders
Hiccups
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
8.5%
5/59 • Number of events 6
|
10.3%
6/58 • Number of events 7
|
30.4%
17/56 • Number of events 29
|
|
Gastrointestinal disorders
Oral Mucosal erythema
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Pelvic Pain
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
proctalgia
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Proctitis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
5.4%
3/56 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
8/59 • Number of events 11
|
8.6%
5/58 • Number of events 7
|
16.1%
9/56 • Number of events 21
|
|
General disorders
Chest Pain
|
5.1%
3/59 • Number of events 3
|
3.4%
2/58 • Number of events 2
|
1.8%
1/56 • Number of events 2
|
|
General disorders
Chills
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 2
|
0.00%
0/56
|
|
General disorders
Condition aggravated
|
0.00%
0/59
|
3.4%
2/58 • Number of events 2
|
3.6%
2/56 • Number of events 2
|
|
General disorders
Fatigue
|
13.6%
8/59 • Number of events 9
|
12.1%
7/58 • Number of events 9
|
14.3%
8/56 • Number of events 11
|
|
General disorders
General physical health deterioration
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
General disorders
Gravitational oedema
|
3.4%
2/59 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Hyperhidrosis
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
General disorders
Hyperpyrexia
|
3.4%
2/59 • Number of events 2
|
0.00%
0/58
|
3.6%
2/56 • Number of events 2
|
|
General disorders
Malaise
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
General disorders
Mucosal Inflammation
|
6.8%
4/59 • Number of events 4
|
6.9%
4/58 • Number of events 6
|
0.00%
0/56
|
|
General disorders
Multi organ failure
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Oedema
|
0.00%
0/59
|
0.00%
0/58
|
5.4%
3/56 • Number of events 3
|
|
General disorders
Oedema Peripheral
|
3.4%
2/59 • Number of events 2
|
5.2%
3/58 • Number of events 9
|
1.8%
1/56 • Number of events 3
|
|
General disorders
Pain
|
3.4%
2/59 • Number of events 2
|
5.2%
3/58 • Number of events 4
|
1.8%
1/56 • Number of events 2
|
|
General disorders
Pyrexia
|
13.6%
8/59 • Number of events 10
|
24.1%
14/58 • Number of events 22
|
25.0%
14/56 • Number of events 22
|
|
Hepatobiliary disorders
Ascites
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Hepatobiliary disorders
Cholangites
|
5.1%
3/59 • Number of events 3
|
3.4%
2/58 • Number of events 3
|
5.4%
3/56 • Number of events 3
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.8%
4/59 • Number of events 10
|
8.6%
5/58 • Number of events 10
|
5.4%
3/56 • Number of events 3
|
|
Hepatobiliary disorders
Hypertrasaminasaemia
|
3.4%
2/59 • Number of events 3
|
3.4%
2/58 • Number of events 2
|
3.6%
2/56 • Number of events 2
|
|
Hepatobiliary disorders
Hypoalbuminaemia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Hepatobiliary disorders
Jaundice
|
3.4%
2/59 • Number of events 3
|
5.2%
3/58 • Number of events 3
|
5.4%
3/56 • Number of events 3
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Immune system disorders
Dermatitis allergic
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Infections and infestations
Cystis escherichia
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Folliculitis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Infections and infestations
Hepatobiliary infection
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Infections and infestations
Influenza
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Infections and infestations
Skin Infection
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Infections and infestations
Tooth abcess
|
0.00%
0/59
|
0.00%
0/58
|
3.6%
2/56 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Infections and infestations
Viral infection
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
1/59 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
1.8%
1/56 • Number of events 1
|
|
Investigations
Aspartate aminotranferase
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Investigations
Asparteate amonotranferase increased
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Investigations
Blood alkaline phosphatase
|
3.4%
2/59 • Number of events 2
|
0.00%
0/58
|
0.00%
0/56
|
|
Investigations
Blood Bilirubin
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Investigations
Blood Bilirubin increased
|
5.1%
3/59 • Number of events 5
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Investigations
Blood creatine
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Investigations
Blood creatinine increased
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Investigations
Blood glucose decreased
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Investigations
Blood lactate dehdrogenase increased
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Investigations
Blood potassium increased
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Investigations
Blood urea increased
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Investigations
Electrocardiogram QT prolonged
|
3.4%
2/59 • Number of events 2
|
3.4%
2/58 • Number of events 2
|
1.8%
1/56 • Number of events 1
|
|
Investigations
Electrocardiogram T wave inversion
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Investigations
Electrocardiogram abnormal
|
3.4%
2/59 • Number of events 3
|
0.00%
0/58
|
0.00%
0/56
|
|
Investigations
Electrocardiogram repolarisation abnormaly
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Investigations
Gamma -glumayltransferase
|
3.4%
2/59 • Number of events 2
|
0.00%
0/58
|
0.00%
0/56
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/59
|
1.7%
1/58 • Number of events 2
|
5.4%
3/56 • Number of events 5
|
|
Investigations
International normalised ratio increased
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Investigations
Platelet count decreased
|
0.00%
0/59
|
5.2%
3/58 • Number of events 3
|
0.00%
0/56
|
|
Investigations
Platelet count increased
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Investigations
Transaminase increased
|
1.7%
1/59 • Number of events 2
|
1.7%
1/58 • Number of events 2
|
0.00%
0/56
|
|
Investigations
Weight decreased
|
3.4%
2/59 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.5%
5/59 • Number of events 5
|
13.8%
8/58 • Number of events 10
|
7.1%
4/56 • Number of events 4
|
|
Metabolism and nutrition disorders
Deydratation
|
3.4%
2/59 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Metabolism and nutrition disorders
Hyperbilirubinaemia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/59
|
3.4%
2/58 • Number of events 2
|
1.8%
1/56 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/59
|
3.4%
2/58 • Number of events 2
|
0.00%
0/56
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
2/59 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
5.4%
3/56 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/59
|
0.00%
0/58
|
3.6%
2/56 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
3.6%
2/56 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Musculoskeletal and connective tissue disorders
Pain in the extremity
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal Compression Fracture
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Nervous system disorders
Clonus
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Nervous system disorders
Convulsion
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Nervous system disorders
Dizziness
|
1.7%
1/59 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
0.00%
0/56
|
|
Nervous system disorders
Dysarthria
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Nervous system disorders
Epilepsy
|
3.4%
2/59 • Number of events 2
|
0.00%
0/58
|
0.00%
0/56
|
|
Nervous system disorders
Head Discomfort
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Headache
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
8.9%
5/56 • Number of events 5
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Nervous system disorders
Insomnia
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Loss of consciousness
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Nervous system disorders
Neuralgia
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Nervous system disorders
Neuropathy peripheral
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Nervous system disorders
Paraesthesia
|
1.7%
1/59 • Number of events 3
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/59
|
3.4%
2/58 • Number of events 3
|
0.00%
0/56
|
|
Nervous system disorders
Somnolence
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Nervous system disorders
Syncope
|
3.4%
2/59 • Number of events 3
|
0.00%
0/58
|
0.00%
0/56
|
|
Nervous system disorders
Tremor
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Psychiatric disorders
Depression
|
1.7%
1/59 • Number of events 2
|
3.4%
2/58 • Number of events 3
|
3.6%
2/56 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Psychiatric disorders
Sleep disorder due to general medical condition , insomnia type
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/59
|
5.2%
3/58 • Number of events 5
|
0.00%
0/56
|
|
Renal and urinary disorders
Haematuria
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Renal and urinary disorders
Hypercreatininaemia
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
Renal and urinary disorders
Oliguria
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
1.7%
1/59 • Number of events 1
|
5.2%
3/58 • Number of events 3
|
1.8%
1/56 • Number of events 5
|
|
Renal and urinary disorders
Renal failure
|
3.4%
2/59 • Number of events 2
|
5.2%
3/58 • Number of events 4
|
1.8%
1/56 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Renal and urinary disorders
Strangury
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Renal and urinary disorders
Urinary incontinence
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Renal and urinary disorders
Urinary Tract Infection
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Respiratory, thoracic and mediastinal disorders
Dysponea
|
5.1%
3/59 • Number of events 3
|
5.2%
3/58 • Number of events 3
|
7.1%
4/56 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dysponea exertional
|
1.7%
1/59 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
0.00%
0/56
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
1/59 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/59
|
3.4%
2/58 • Number of events 2
|
0.00%
0/56
|
|
Ear and labyrinth disorders
Vertigo
|
3.4%
2/59 • Number of events 2
|
0.00%
0/58
|
0.00%
0/56
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastic Neoplasm
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastic Pain
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor associated fever
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.4%
2/59 • Number of events 8
|
5.2%
3/58 • Number of events 4
|
0.00%
0/56
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.4%
2/59 • Number of events 2
|
0.00%
0/58
|
3.6%
2/56 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.5%
5/59 • Number of events 13
|
6.9%
4/58 • Number of events 4
|
7.1%
4/56 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Skin and subcutaneous tissue disorders
Face Oedema
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
5.1%
3/59 • Number of events 4
|
1.7%
1/58 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
3.4%
2/59 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.7%
1/59 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
7.1%
4/56 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.4%
15/59 • Number of events 21
|
8.6%
5/58 • Number of events 5
|
5.4%
3/56 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
3.4%
2/59 • Number of events 2
|
0.00%
0/58
|
0.00%
0/56
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Skin and subcutaneous tissue disorders
Skin Toxicity
|
3.4%
2/59 • Number of events 6
|
5.2%
3/58 • Number of events 3
|
1.8%
1/56 • Number of events 1
|
|
Vascular disorders
Diastolic hypotension
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Vascular disorders
Epistaxis
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Vascular disorders
Essential hypertension
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Vascular disorders
Haemorrhoids
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Vascular disorders
Hypertension
|
23.7%
14/59 • Number of events 17
|
15.5%
9/58 • Number of events 10
|
7.1%
4/56 • Number of events 6
|
|
Vascular disorders
Hypertensive crisis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
|
Vascular disorders
Hypotension
|
3.4%
2/59 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
0.00%
0/59
|
0.00%
0/58
|
1.8%
1/56 • Number of events 2
|
|
Vascular disorders
Pulmonary embolism
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
|
Vascular disorders
Venous thrombosis limb
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Hepatobiliary disorders
Hepatic pain
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Immune system disorders
Contrast media allergy
|
1.7%
1/59 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
|
Investigations
Urine colour abnormal
|
0.00%
0/59
|
1.7%
1/58 • Number of events 1
|
0.00%
0/56
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER