Trial Outcomes & Findings for A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (NCT NCT02406742)
NCT ID: NCT02406742
Last Updated: 2021-09-20
Results Overview
Number and severity of adverse events using the NCI CTCAE criteria (version 4.03), including DLTs
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Approximately 60 Months
Results posted on
2021-09-20
Participant Flow
46 participants treated
Participant milestones
| Measure |
Arm A
CC-122 single agent Dose Escalation
|
Arm B
CC-122 in combination with ibrutinib Dose Escalation
|
Arm C
CC-122 in combination with obinutuzumab Dose Escalation
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
16
|
|
Overall Study
Dose Escalation 1
|
3
|
0
|
0
|
|
Overall Study
Dose Escalation 2
|
9
|
5
|
3
|
|
Overall Study
Dose Escalation 3
|
2
|
3
|
3
|
|
Overall Study
Dose Escalation 4
|
0
|
3
|
3
|
|
Overall Study
Dose Escalation 5
|
0
|
5
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
16
|
16
|
Reasons for withdrawal
| Measure |
Arm A
CC-122 single agent Dose Escalation
|
Arm B
CC-122 in combination with ibrutinib Dose Escalation
|
Arm C
CC-122 in combination with obinutuzumab Dose Escalation
|
|---|---|---|---|
|
Overall Study
Progression of Disease
|
5
|
1
|
6
|
|
Overall Study
Adverse Event
|
3
|
0
|
2
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Participant
|
1
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
2
|
1
|
|
Overall Study
Transition to other treatment
|
2
|
0
|
1
|
|
Overall Study
Other Reasons
|
1
|
11
|
5
|
Baseline Characteristics
A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A
n=14 Participants
CC-122 single agent Dose Escalation
|
Arm B
n=16 Participants
CC-122 in combination with ibrutinib Dose Escalation
|
Arm C
n=16 Participants
CC-122 in combination with obinutuzumab Dose Escalation
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.4 Years
STANDARD_DEVIATION 9.41 • n=5 Participants
|
63.4 Years
STANDARD_DEVIATION 9.98 • n=7 Participants
|
61.5 Years
STANDARD_DEVIATION 6.11 • n=5 Participants
|
64.0 Years
STANDARD_DEVIATION 8.78 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Approximately 60 MonthsPopulation: Safety Population
Number and severity of adverse events using the NCI CTCAE criteria (version 4.03), including DLTs
Outcome measures
| Measure |
Arm A
n=14 Participants
CC-122 single agent Dose Escalation
|
Arm B
n=16 Participants
CC-122 in combination with ibrutinib Dose Escalation
|
Arm C
n=16 Participants
CC-122 in combination with obinutuzumab Dose Escalation
|
|---|---|---|---|
|
Number of Participants and Severity of AEs
Grade 3 AE
|
8 Number
|
8 Number
|
9 Number
|
|
Number of Participants and Severity of AEs
Grade 4 AE
|
3 Number
|
5 Number
|
7 Number
|
|
Number of Participants and Severity of AEs
DLTs
|
0 Number
|
0 Number
|
0 Number
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Safety Population
Determination of the NTD and MTD in CC-122 in combination with ibrutinib and CC-122 in combination with obinutuzumab
Outcome measures
| Measure |
Arm A
CC-122 single agent Dose Escalation
|
Arm B
n=16 Participants
CC-122 in combination with ibrutinib Dose Escalation
|
Arm C
n=16 Participants
CC-122 in combination with obinutuzumab Dose Escalation
|
|---|---|---|---|
|
Determination of Non Tolerated Dose (NTD) and Maximum Tolerated Dose (MTD)
NTD
|
—
|
NA mg
NTD was not reached
|
NA mg
NTD was not reached
|
|
Determination of Non Tolerated Dose (NTD) and Maximum Tolerated Dose (MTD)
MTD
|
—
|
NA mg
MTD was not reached
|
NA mg
MTD was not reached
|
SECONDARY outcome
Timeframe: Approximately 60 MonthsPopulation: PK Population
CC-122 plasma concentrations when administered alone or in combination with ibrutinib or obinutuzumab
Outcome measures
| Measure |
Arm A
n=14 Participants
CC-122 single agent Dose Escalation
|
Arm B
n=7 Participants
CC-122 in combination with ibrutinib Dose Escalation
|
Arm C
n=5 Participants
CC-122 in combination with obinutuzumab Dose Escalation
|
|---|---|---|---|
|
CC-122 Plasma Concentrations When Administered Alone or in Combination With Ibrutinib or Obinutuzumab
|
NA Percentage
Geometric Coefficient of Variation NA
insufficient number of participants with events
|
NA Percentage
Geometric Coefficient of Variation NA
insufficient number of participants with events
|
NA Percentage
Geometric Coefficient of Variation NA
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Approximately 60 MonthsPopulation: PK Population
Geometric mean concentration of Ibrutinib when administered alone or in combination with CC-122
Outcome measures
| Measure |
Arm A
n=14 Participants
CC-122 single agent Dose Escalation
|
Arm B
n=7 Participants
CC-122 in combination with ibrutinib Dose Escalation
|
Arm C
n=5 Participants
CC-122 in combination with obinutuzumab Dose Escalation
|
|---|---|---|---|
|
Ibrutinib Plasma Concentrations When Administered in Combination With CC-122
|
NA Percentage
Geometric Coefficient of Variation NA
insufficient number of participants with events
|
NA Percentage
Geometric Coefficient of Variation NA
insufficient number of participants with events
|
NA Percentage
Geometric Coefficient of Variation NA
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Approximately 60 MonthsPopulation: Safety Population
Best overall response \[CR, CRi, nPR, PR, PRL (applicable to Arm B only)\] CR = Complete Response CRi = Complete response with incomplete marrow recovery nPR = nodular Partial Response PR = Partial response PRL= Partial response with lymphocytosis
Outcome measures
| Measure |
Arm A
n=14 Participants
CC-122 single agent Dose Escalation
|
Arm B
n=16 Participants
CC-122 in combination with ibrutinib Dose Escalation
|
Arm C
n=16 Participants
CC-122 in combination with obinutuzumab Dose Escalation
|
|---|---|---|---|
|
Best Overall Response (BOR)
|
7.1 Percentage
Interval 0.2 to 33.9
|
87.5 Percentage
Interval 61.7 to 98.4
|
62.5 Percentage
Interval 35.4 to 84.8
|
SECONDARY outcome
Timeframe: Approximately 60 MonthsPopulation: Safety Population
Minimal Residual Disease Response Rate in bone marrow and peripheral blood
Outcome measures
| Measure |
Arm A
n=14 Participants
CC-122 single agent Dose Escalation
|
Arm B
n=16 Participants
CC-122 in combination with ibrutinib Dose Escalation
|
Arm C
n=16 Participants
CC-122 in combination with obinutuzumab Dose Escalation
|
|---|---|---|---|
|
Minimal Residual Disease Response Rate
Bone Marrow
|
0 Percentage
Interval 0.0 to 23.2
|
0 Percentage
Interval 0.0 to 20.6
|
0 Percentage
Interval 0.0 to 20.6
|
|
Minimal Residual Disease Response Rate
Peripheral Blood
|
0 Percentage
Interval 0.0 to 23.2
|
0 Percentage
Interval 0.0 to 20.6
|
18.8 Percentage
Interval 4.0 to 45.6
|
SECONDARY outcome
Timeframe: Approximately 60 MonthsPopulation: Safety population with Tumor response
measured from the time the response is first met until the first date that progressive disease or death is documented. Participants who neither progress nor die or who withdrew consent or are lost to follow-up prior to documentation of progression will be censored at the date of their last adequate response assessment.
Outcome measures
| Measure |
Arm A
n=1 Participants
CC-122 single agent Dose Escalation
|
Arm B
n=14 Participants
CC-122 in combination with ibrutinib Dose Escalation
|
Arm C
n=10 Participants
CC-122 in combination with obinutuzumab Dose Escalation
|
|---|---|---|---|
|
Duration of Response
|
113 Days
insufficient number of deaths to derive data
|
NA Days
insufficient number of deaths to derive data
|
602.0 Days
insufficient number of deaths to derive data
|
SECONDARY outcome
Timeframe: Approximately 60 MonthsPopulation: Safety Population
will be calculated as the time from irst IP (i.e. any study drug) dose date to the first documented progression or death due to any cause during or after the treatment period, whichever occurs first.
Outcome measures
| Measure |
Arm A
n=14 Participants
CC-122 single agent Dose Escalation
|
Arm B
n=16 Participants
CC-122 in combination with ibrutinib Dose Escalation
|
Arm C
n=16 Participants
CC-122 in combination with obinutuzumab Dose Escalation
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
6.47 Months
Interval 0.43 to 12.29
|
NA Months
Insufficient number of participants
|
22.57 Months
Interval 5.55 to
Insufficient number of participants
|
SECONDARY outcome
Timeframe: Approximately 60 MonthsPopulation: Intensive PK Population
Peak (maximum) drug plasma concentration
Outcome measures
| Measure |
Arm A
n=5 Participants
CC-122 single agent Dose Escalation
|
Arm B
CC-122 in combination with ibrutinib Dose Escalation
|
Arm C
CC-122 in combination with obinutuzumab Dose Escalation
|
|---|---|---|---|
|
Cmax When Administered Alone or in Combination With Ibrutinib
|
NA mg/mL
insufficient number of participants with events
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 60 MonthsPopulation: Intensive PK Population
Time to peak (maximum) drug concentration
Outcome measures
| Measure |
Arm A
n=5 Participants
CC-122 single agent Dose Escalation
|
Arm B
CC-122 in combination with ibrutinib Dose Escalation
|
Arm C
CC-122 in combination with obinutuzumab Dose Escalation
|
|---|---|---|---|
|
Tmax of CC-122 When Administered Alone or in Combination With Ibrutinib
|
NA hours
insufficient number of participants with events
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 60 MonthsPopulation: Intensive PK Population
Area under the concentration -time curve calculated to the last observable concentration at time t
Outcome measures
| Measure |
Arm A
n=5 Participants
CC-122 single agent Dose Escalation
|
Arm B
CC-122 in combination with ibrutinib Dose Escalation
|
Arm C
CC-122 in combination with obinutuzumab Dose Escalation
|
|---|---|---|---|
|
AUC of CC-122 When Administered Alone or in Combination With Ibrutinib
|
NA Percentage
insufficient number of participants with events
|
—
|
—
|
Adverse Events
A (CC-122)
Serious events: 7 serious events
Other events: 14 other events
Deaths: 2 deaths
B (CC-122+Ibrutinib)
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
C (CC-122+Obinutuzumab)
Serious events: 4 serious events
Other events: 16 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
A (CC-122)
n=14 participants at risk
CC-122 single agent
|
B (CC-122+Ibrutinib)
n=16 participants at risk
CC-122 in combination with ibrutinib
|
C (CC-122+Obinutuzumab)
n=16 participants at risk
CC-122 in combination with obinutuzumab
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
14.3%
2/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
General disorders
Pyrexia
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Bacteraemia
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Candida sepsis
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Enterococcal sepsis
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Influenza
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Pneumonia
|
21.4%
3/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Sepsis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Investigations
Troponin increased
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Nervous system disorders
Syncope
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
Other adverse events
| Measure |
A (CC-122)
n=14 participants at risk
CC-122 single agent
|
B (CC-122+Ibrutinib)
n=16 participants at risk
CC-122 in combination with ibrutinib
|
C (CC-122+Obinutuzumab)
n=16 participants at risk
CC-122 in combination with obinutuzumab
|
|---|---|---|---|
|
Nervous system disorders
Memory impairment
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/14 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Nervous system disorders
Presyncope
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Nervous system disorders
Syncope
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Nervous system disorders
Tremor
|
7.1%
1/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Product Issues
Device occlusion
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Psychiatric disorders
Depression
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Psychiatric disorders
Irritability
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Renal and urinary disorders
Strangury
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Renal and urinary disorders
Urethral haemorrhage
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
3/14 • Approximately 60 Months
|
31.2%
5/16 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
1/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • Approximately 60 Months
|
50.0%
8/16 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.1%
1/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
28.6%
4/14 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/14 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/14 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
7.1%
1/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/14 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/14 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Vascular disorders
Flushing
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Vascular disorders
Haematoma
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Vascular disorders
Hot flush
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Vascular disorders
Hypertension
|
14.3%
2/14 • Approximately 60 Months
|
37.5%
6/16 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
|
Vascular disorders
Systolic hypertension
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Vascular disorders
Thrombophlebitis superficial
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Balanitis candida
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Body tinea
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Cystitis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Diverticulitis
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Blood and lymphatic system disorders
Anaemia
|
57.1%
8/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
31.2%
5/16 • Approximately 60 Months
|
|
Blood and lymphatic system disorders
Lymph node pain
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/14 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
43.8%
7/16 • Approximately 60 Months
|
|
Blood and lymphatic system disorders
Neutropenia
|
35.7%
5/14 • Approximately 60 Months
|
37.5%
6/16 • Approximately 60 Months
|
81.2%
13/16 • Approximately 60 Months
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
2/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
37.5%
6/16 • Approximately 60 Months
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Cardiac disorders
Sinus bradycardia
|
7.1%
1/14 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Cardiac disorders
Tricuspid valve incompetence
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Cardiac disorders
Ventricular hypertrophy
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Ear and labyrinth disorders
Autophony
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Ear and labyrinth disorders
Vertigo
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Eye disorders
Cataract
|
7.1%
1/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Eye disorders
Chalazion
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Eye disorders
Conjunctival haemorrhage
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Eye disorders
Diplopia
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Eye disorders
Dry eye
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Eye disorders
Dyschromatopsia
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Eye disorders
Eye irritation
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Eye disorders
Eye pain
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Eye disorders
Macular degeneration
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Eye disorders
Maculopathy
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Eye disorders
Photophobia
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Eye disorders
Photopsia
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Eye disorders
Vision blurred
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Eye disorders
Visual impairment
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
3/14 • Approximately 60 Months
|
43.8%
7/16 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Gastrointestinal polyp
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Approximately 60 Months
|
43.8%
7/16 • Approximately 60 Months
|
31.2%
5/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
7.1%
1/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/14 • Approximately 60 Months
|
43.8%
7/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Umbilical hernia
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
General disorders
Asthenia
|
21.4%
3/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
General disorders
Catheter site bruise
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
General disorders
Chest pain
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
General disorders
Chills
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
General disorders
Fatigue
|
21.4%
3/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
31.2%
5/16 • Approximately 60 Months
|
|
General disorders
Feeling hot
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
General disorders
Influenza like illness
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
General disorders
Injection site pain
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
General disorders
Malaise
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
General disorders
Non-cardiac chest pain
|
7.1%
1/14 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
General disorders
Oedema peripheral
|
21.4%
3/14 • Approximately 60 Months
|
43.8%
7/16 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
|
General disorders
Pain
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
General disorders
Peripheral swelling
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
General disorders
Pyrexia
|
35.7%
5/14 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Fungal balanitis
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Gingivitis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Infection
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Influenza
|
0.00%
0/14 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
31.2%
5/16 • Approximately 60 Months
|
|
Infections and infestations
Oral candidiasis
|
7.1%
1/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Oral herpes
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Pseudomonal sepsis
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
|
Infections and infestations
Skin infection
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Tinea infection
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Tooth infection
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • Approximately 60 Months
|
37.5%
6/16 • Approximately 60 Months
|
31.2%
5/16 • Approximately 60 Months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Infections and infestations
Wound infection
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Buttock injury
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Dental restoration failure
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14 • Approximately 60 Months
|
37.5%
6/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
43.8%
7/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Investigations
Amylase increased
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Investigations
Blood creatine phosphokinase increased
|
14.3%
2/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Investigations
Blood creatinine increased
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Investigations
Hepatic enzyme increased
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Investigations
Lipase increased
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Investigations
Occult blood positive
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Investigations
Weight decreased
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
|
Investigations
Weight increased
|
0.00%
0/14 • Approximately 60 Months
|
37.5%
6/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/14 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Folate deficiency
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.1%
1/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Iron deficiency
|
7.1%
1/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
18.8%
3/16 • Approximately 60 Months
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
2/14 • Approximately 60 Months
|
31.2%
5/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
1/14 • Approximately 60 Months
|
31.2%
5/16 • Approximately 60 Months
|
25.0%
4/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
2/14 • Approximately 60 Months
|
31.2%
5/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
14.3%
2/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/14 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Approximately 60 Months
|
31.2%
5/16 • Approximately 60 Months
|
6.2%
1/16 • Approximately 60 Months
|
|
Nervous system disorders
Dizziness postural
|
7.1%
1/14 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
0.00%
0/16 • Approximately 60 Months
|
|
Nervous system disorders
Headache
|
21.4%
3/14 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
12.5%
2/16 • Approximately 60 Months
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60