Trial Outcomes & Findings for Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) With a Sequential Switch to a 2nd IMT (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NCT NCT02179671)
NCT ID: NCT02179671
Last Updated: 2019-08-02
Results Overview
To assess the efficacy of various sequences. CR (per RECIST 1.1 as assessed by the local/site Investigator) is defined as the disappearance of all target and non-target lesions. Confirmed complete response rate (CR rate) is defined as the number (%) of patients with a confirmed overall response of CR and was based on the evaluable analysis set.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2019-08-02
Participant Flow
This study was conducted at 10 study centers in United States. The first subject was enrolled on 25 July 2014.
Due to the small numbers of patients treated in Cohorts A through C (gefitinib, AZD9291, or selumetinib + docetaxel), statistical analyses were only done and summary tables prepared for the 28 patients randomised to Cohort D (tremelimumab, either 1-cycle or 2-cycles).
Participant milestones
| Measure |
Gefitinib With a Seq. Switch to a MEDI4736
Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
|
AZD9291 With a Seq. Switch to a MEDI4736
The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database.
|
Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736
Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
|
Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736
Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
|
Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736
Tremelimumab every 4 weeks (2 cycles) followed by MEDI4736
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
2
|
14
|
14
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
13
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) With a Sequential Switch to a 2nd IMT (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Gefitinib With a Seq. Switch to a MEDI4736
n=1 Participants
Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
|
Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736
n=2 Participants
Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
|
Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736
n=14 Participants
Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
|
Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736
n=13 Participants
TREMELIMUMAB 10MG/KG Q4W 8WEEKS/MEDI4736 10MG/KG Q2W 12MONTHS
|
AZD9291 With a Seq. Switch to a MEDI4736
The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
79.0 Years
STANDARD_DEVIATION 0 • n=93 Participants
|
65.0 Years
STANDARD_DEVIATION 12.73 • n=4 Participants
|
57.8 Years
STANDARD_DEVIATION 12.05 • n=27 Participants
|
64.3 Years
STANDARD_DEVIATION 7.85 • n=483 Participants
|
—
|
61.8 Years
STANDARD_DEVIATION 10.85 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
—
|
11 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
—
|
19 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
—
|
23 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
—
|
4 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients.
To assess the efficacy of various sequences. CR (per RECIST 1.1 as assessed by the local/site Investigator) is defined as the disappearance of all target and non-target lesions. Confirmed complete response rate (CR rate) is defined as the number (%) of patients with a confirmed overall response of CR and was based on the evaluable analysis set.
Outcome measures
| Measure |
AZD9291 With a Seq. Switch to a MEDI4736
The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database.
|
Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736
Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
|
Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736
n=9 Participants
Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
|
Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736
n=7 Participants
Tremelimumab every 4 weeks (2 cycles) followed by MEDI4736
|
Gefitinib With a Seq. Switch to a MEDI4736
Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
|
|---|---|---|---|---|---|
|
Confirmed Complete Response (CR) Rate
|
—
|
—
|
0 patients (%)
CR=0
|
0 patients (%)
CR=0
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients.
To further assess the efficacy of various sequences. Objective response rate (ORR; per RECIST 1.1 as assessed by the site Investigator) is defined as the number (%) of patients with a confirmed overall response of CR or PR and was based on the evaluable analysis set. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
AZD9291 With a Seq. Switch to a MEDI4736
The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database.
|
Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736
Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
|
Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736
n=9 Participants
Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
|
Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736
n=7 Participants
Tremelimumab every 4 weeks (2 cycles) followed by MEDI4736
|
Gefitinib With a Seq. Switch to a MEDI4736
Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
—
|
—
|
11.1 patients (%)
Interval 1.2 to 36.8
|
0 patients (%)
ORR=0
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients.
Progression-free survival (per RECIST 1.1 as assessed by Investigator) is defined as the date of 1st dose of MEDI4736 until the date of objective disease progression or death. Progression of disease (PD) At least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
AZD9291 With a Seq. Switch to a MEDI4736
The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database.
|
Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736
Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
|
Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736
n=9 Participants
Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
|
Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736
n=7 Participants
Tremelimumab every 4 weeks (2 cycles) followed by MEDI4736
|
Gefitinib With a Seq. Switch to a MEDI4736
Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
|
|---|---|---|---|---|---|
|
Progression-free Survival
|
—
|
—
|
1 patients
|
0 patients
|
—
|
SECONDARY outcome
Timeframe: Within 12 monthsPopulation: Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients. Response was observed for 1 patient in the Tremelimumab 1-cycle arm for up to and including 6 months.
Duration of response (DoR; per RECIST 1.1 as assessed by the site Investigator) will be defined as the time from the date of 1st documented response (which is subsequently confirmed) until the 1st date of documented progression or death in the absence of disease progression.
Outcome measures
| Measure |
AZD9291 With a Seq. Switch to a MEDI4736
The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database.
|
Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736
Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
|
Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736
n=1 Participants
Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
|
Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736
Tremelimumab every 4 weeks (2 cycles) followed by MEDI4736
|
Gefitinib With a Seq. Switch to a MEDI4736
Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
|
|---|---|---|---|---|---|
|
Duration of Response
|
—
|
—
|
NA Months
Median was not reached.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients.
To assess the efficacy of various sequences. In survival follow up at data cut off.
Outcome measures
| Measure |
AZD9291 With a Seq. Switch to a MEDI4736
The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database.
|
Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736
Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
|
Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736
n=9 Participants
Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
|
Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736
n=7 Participants
Tremelimumab every 4 weeks (2 cycles) followed by MEDI4736
|
Gefitinib With a Seq. Switch to a MEDI4736
Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
|
|---|---|---|---|---|---|
|
Overall Survival
|
—
|
—
|
0 patients
|
0 patients
|
—
|
Adverse Events
Gefitinib With a Seq. Switch to a MEDI4736
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
AZD9291 With a Seq. Switch to MEDI4736
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736
Serious events: 8 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gefitinib With a Seq. Switch to a MEDI4736
n=1 participants at risk
Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
|
Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736
n=2 participants at risk
Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
|
AZD9291 With a Seq. Switch to MEDI4736
The 1 patient in the AZD9291 cohort was not dosed and no data were recorded in the database.
|
Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736
n=14 participants at risk
Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
|
Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736
n=13 participants at risk
TREMELIMUMAB 10MG/KG Q4W 8WEEKS/MEDI4736 10MG/KG Q2W 12MONTHS
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
0.00%
0/14
|
0.00%
0/13
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
General disorders
Pyrexia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
0.00%
0/14
|
0.00%
0/13
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
0.00%
0/14
|
0.00%
0/13
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
14.3%
2/14 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
15.4%
2/13 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Seizure
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
Gefitinib With a Seq. Switch to a MEDI4736
n=1 participants at risk
Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
|
Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736
n=2 participants at risk
Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
|
AZD9291 With a Seq. Switch to MEDI4736
The 1 patient in the AZD9291 cohort was not dosed and no data were recorded in the database.
|
Tremelimumab (1 Cycle) With a Seq. Switch to a MEDI4736
n=14 participants at risk
Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
|
Tremelimumab (2 Cycles) With a Seq. Switch to MEDI4736
n=13 participants at risk
TREMELIMUMAB 10MG/KG Q4W 8WEEKS/MEDI4736 10MG/KG Q2W 12MONTHS
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
14.3%
2/14 • Number of events 2
|
30.8%
4/13 • Number of events 5
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
0.00%
0/14
|
0.00%
0/13
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
14.3%
2/14 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Eye disorders
Eye disorder
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
14.3%
2/14 • Number of events 3
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1
|
100.0%
2/2 • Number of events 2
|
—
0/0
|
21.4%
3/14 • Number of events 3
|
15.4%
2/13 • Number of events 2
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1
|
100.0%
2/2 • Number of events 2
|
—
0/0
|
42.9%
6/14 • Number of events 10
|
23.1%
3/13 • Number of events 4
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1
|
100.0%
2/2 • Number of events 2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
28.6%
4/14 • Number of events 5
|
30.8%
4/13 • Number of events 7
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
14.3%
2/14 • Number of events 2
|
0.00%
0/13
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1
|
100.0%
2/2 • Number of events 3
|
—
0/0
|
28.6%
4/14 • Number of events 6
|
23.1%
3/13 • Number of events 5
|
|
General disorders
Chills
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
14.3%
2/14 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
42.9%
6/14 • Number of events 6
|
38.5%
5/13 • Number of events 5
|
|
General disorders
Gait disturbance
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Inflammation
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 2
|
0.00%
0/13
|
|
General disorders
Influenza like illness
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
14.3%
2/14 • Number of events 3
|
0.00%
0/13
|
|
General disorders
Local swelling
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Oedema peripheral
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
38.5%
5/13 • Number of events 6
|
|
General disorders
Pyrexia
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
21.4%
3/14 • Number of events 4
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Candida infection
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Furuncle
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Infections and infestations
Implant site infection
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 2
|
|
Infections and infestations
Influenza
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Rash pustular
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 2
|
|
Infections and infestations
Rhinitis
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
100.0%
1/1 • Number of events 1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
0.00%
0/13
|
|
Infections and infestations
Urinary tract infection
|
100.0%
1/1 • Number of events 1
|
0.00%
0/2
|
—
0/0
|
14.3%
2/14 • Number of events 3
|
7.7%
1/13 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
15.4%
2/13 • Number of events 2
|
|
Investigations
Blood glucose increased
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Blood sodium increased
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Blood urea increased
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Weight decreased
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
30.8%
4/13 • Number of events 4
|
|
Investigations
White blood cell count increased
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
21.4%
3/14 • Number of events 3
|
23.1%
3/13 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
14.3%
2/14 • Number of events 3
|
23.1%
3/13 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
15.4%
2/13 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
23.1%
3/13 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
21.4%
3/14 • Number of events 5
|
30.8%
4/13 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
100.0%
1/1 • Number of events 1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
15.4%
2/13 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
23.1%
3/13 • Number of events 3
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
15.4%
2/13 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1
|
100.0%
2/2 • Number of events 2
|
—
0/0
|
0.00%
0/14
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
14.3%
2/14 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Amnesia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Aphasia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
0.00%
0/14
|
15.4%
2/13 • Number of events 2
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
23.1%
3/13 • Number of events 3
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
14.3%
2/14 • Number of events 2
|
0.00%
0/13
|
|
Product Issues
Thrombosis in device
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
0.00%
0/14
|
0.00%
0/13
|
|
Psychiatric disorders
Agitation
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
|
Psychiatric disorders
Delirium
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
14.3%
2/14 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Renal and urinary disorders
Haematuria
|
100.0%
1/1 • Number of events 1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Renal and urinary disorders
Micturition urgency
|
100.0%
1/1 • Number of events 1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
0.00%
0/13
|
|
Renal and urinary disorders
Pollakiuria
|
100.0%
1/1 • Number of events 1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
0.00%
0/13
|
|
Renal and urinary disorders
Urethral pain
|
100.0%
1/1 • Number of events 1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Number of events 1
|
0.00%
0/2
|
—
0/0
|
35.7%
5/14 • Number of events 5
|
15.4%
2/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
15.4%
2/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1
|
50.0%
1/2 • Number of events 2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
23.1%
3/13 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
30.8%
4/13 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
100.0%
1/1 • Number of events 1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
14.3%
2/14 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
14.3%
2/14 • Number of events 2
|
23.1%
3/13 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1
|
100.0%
2/2 • Number of events 2
|
—
0/0
|
21.4%
3/14 • Number of events 5
|
15.4%
2/13 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
14.3%
2/14 • Number of events 3
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
100.0%
1/1 • Number of events 1
|
0.00%
0/2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Flushing
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Hot flush
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Vascular disorders
Hypertension
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/1
|
50.0%
1/2 • Number of events 2
|
—
0/0
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 2
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place