Trial Outcomes & Findings for Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer (NCT NCT00706030)
NCT ID: NCT00706030
Last Updated: 2018-08-09
Results Overview
Overall Response Rate (ORR), subjects with CR or PR by independent review in subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
92 participants
Primary outcome timeframe
From first dose date to progression or last tumor assessment, up to four years and six months.
Results posted on
2018-08-09
Participant Flow
Participant milestones
| Measure |
Neratinib 160 mg + Vinorelbine 25 mg/m²
Neratinib 160 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks
|
Neratinib 240 mg + Vinorelbine 25 mg/m²
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks
|
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
|
Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
64
|
16
|
|
Overall Study
Treated
|
6
|
6
|
64
|
15
|
|
Overall Study
COMPLETED
|
0
|
0
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
60
|
16
|
Reasons for withdrawal
| Measure |
Neratinib 160 mg + Vinorelbine 25 mg/m²
Neratinib 160 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks
|
Neratinib 240 mg + Vinorelbine 25 mg/m²
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks
|
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
|
Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
|
|---|---|---|---|---|
|
Overall Study
Disease Progression
|
4
|
6
|
46
|
12
|
|
Overall Study
Adverse Event
|
1
|
0
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
2
|
0
|
|
Overall Study
Not recorded
|
0
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
1
|
|
Overall Study
Failed to return
|
0
|
0
|
1
|
0
|
|
Overall Study
Symptomatic Deterioration
|
0
|
0
|
1
|
0
|
|
Overall Study
No treatment received
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Neratinib 160 mg + Vinorelbine 25 mg/m²
n=6 Participants
Neratinib 160 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks
|
Neratinib 240 mg + Vinorelbine 25 mg/m²
n=6 Participants
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks
|
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib
n=64 Participants
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
|
Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib
n=15 Participants
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 14.8 • n=99 Participants
|
54.3 years
STANDARD_DEVIATION 13.9 • n=107 Participants
|
51.1 years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
52.1 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
51.6 years
STANDARD_DEVIATION 10.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
89 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
61 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From first dose date to progression or last tumor assessment, up to four years and six months.Population: Safety population
Overall Response Rate (ORR), subjects with CR or PR by independent review in subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Outcome measures
| Measure |
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib
n=64 Participants
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
|
Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib
n=15 Participants
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
|
|---|---|---|
|
Overall Response Rate
|
35.9 percentage of participants
Interval 24.3 to 48.9
|
13.3 percentage of participants
Interval 1.7 to 40.5
|
PRIMARY outcome
Timeframe: From Day 1 to Day 21.Population: Safety population of Study Part 1. Treated set including patients eligible for MTD determination.
Maximum Tolerated Dose (MTD) of Neratinib in combination with vinorelbine in subjects with advanced solid tumors.
Outcome measures
| Measure |
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib
n=12 Participants
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
|
Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
|
|---|---|---|
|
Maximum Tolerated Dose
|
240 mg
|
—
|
SECONDARY outcome
Timeframe: From first dose date to progression or last tumor assessment, up to four years and six months.Population: Safety population
Percentage of participants with partial response (PR) or complete response (CR) or stable disease \> 24 weeks by independent assessment for subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Outcome measures
| Measure |
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib
n=64 Participants
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
|
Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib
n=15 Participants
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
|
|---|---|---|
|
Clinical Benefit Rate
|
64.1 percentage of participants
Interval 51.1 to 75.7
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
SECONDARY outcome
Timeframe: From first dose date to progression or death, up to four years and six months.Population: Evaluable population, independent assessment.
Number of weeks between the date of the first dose of test article and the first date of disease recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (v1.0), as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the nadir LD, meaning the smallest sum of the LDs recorded since the treatment started; or unequivocal progression of existing nontarget lesions; or the appearance of any new lesions.
Outcome measures
| Measure |
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib
n=56 Participants
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
|
Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib
n=12 Participants
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
|
|---|---|---|
|
Progression-Free Survival
|
48.0 weeks
Interval 30.9 to 65.1
|
22.7 weeks
Interval 12.0 to 41.0
|
SECONDARY outcome
Timeframe: From start date of response to first PD/death, up to four years and six months.Population: Subjects in evaluable population who had CR or PR according to Independent Assessment.
Duration of response for subjects who had complete or partial response from first response to disease progression, death or last assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Outcome measures
| Measure |
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib
n=23 Participants
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
|
Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib
n=1 Participants
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
|
|---|---|---|
|
Duration Of Response
|
52.7 weeks
Interval 11.6 to 96.1
|
77.7 weeks
Interval 77.7 to 77.7
|
Adverse Events
Neratinib 160 mg + Vinorelbine 25 mg/m²
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Neratinib 240 mg + Vinorelbine 25 mg/m²
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib
Serious events: 21 serious events
Other events: 64 other events
Deaths: 0 deaths
Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neratinib 160 mg + Vinorelbine 25 mg/m²
n=6 participants at risk
Neratinib 160 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks.
|
Neratinib 240 mg + Vinorelbine 25 mg/m²
n=6 participants at risk
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks.
|
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib
n=64 participants at risk
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure.
|
Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib
n=15 participants at risk
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
6.2%
4/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
4.7%
3/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
General disorders
Disease progression
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
General disorders
Fatigue
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
3.1%
2/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
4.7%
3/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Grand mal convulsion
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Renal and urinary disorders
Ureteric haemorrhage
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Surgical and medical procedures
Mastectomy
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
Other adverse events
| Measure |
Neratinib 160 mg + Vinorelbine 25 mg/m²
n=6 participants at risk
Neratinib 160 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks.
|
Neratinib 240 mg + Vinorelbine 25 mg/m²
n=6 participants at risk
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks.
|
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib
n=64 participants at risk
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure.
|
Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib
n=15 participants at risk
Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
23.4%
15/64 • From first dose through 28 days after last dose, up to four years and six months.
|
33.3%
5/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
32.8%
21/64 • From first dose through 28 days after last dose, up to four years and six months.
|
13.3%
2/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
3/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
56.2%
36/64 • From first dose through 28 days after last dose, up to four years and six months.
|
60.0%
9/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
7.8%
5/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
7.8%
5/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Eye disorders
Eye irritation
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
7.8%
5/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
6.2%
4/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
34.4%
22/64 • From first dose through 28 days after last dose, up to four years and six months.
|
26.7%
4/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
12.5%
8/64 • From first dose through 28 days after last dose, up to four years and six months.
|
20.0%
3/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
83.3%
5/6 • From first dose through 28 days after last dose, up to four years and six months.
|
15.6%
10/64 • From first dose through 28 days after last dose, up to four years and six months.
|
20.0%
3/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
6/6 • From first dose through 28 days after last dose, up to four years and six months.
|
100.0%
6/6 • From first dose through 28 days after last dose, up to four years and six months.
|
95.3%
61/64 • From first dose through 28 days after last dose, up to four years and six months.
|
100.0%
15/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
7.8%
5/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Gingival ulceration
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
9.4%
6/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
15.6%
10/64 • From first dose through 28 days after last dose, up to four years and six months.
|
13.3%
2/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • From first dose through 28 days after last dose, up to four years and six months.
|
50.0%
3/6 • From first dose through 28 days after last dose, up to four years and six months.
|
54.7%
35/64 • From first dose through 28 days after last dose, up to four years and six months.
|
46.7%
7/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
12.5%
8/64 • From first dose through 28 days after last dose, up to four years and six months.
|
13.3%
2/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Tongue discolouration
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
37.5%
24/64 • From first dose through 28 days after last dose, up to four years and six months.
|
66.7%
10/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
General disorders
Asthenia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
25.0%
16/64 • From first dose through 28 days after last dose, up to four years and six months.
|
33.3%
5/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
General disorders
Chest discomfort
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
General disorders
Fatigue
|
50.0%
3/6 • From first dose through 28 days after last dose, up to four years and six months.
|
50.0%
3/6 • From first dose through 28 days after last dose, up to four years and six months.
|
37.5%
24/64 • From first dose through 28 days after last dose, up to four years and six months.
|
26.7%
4/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
7.8%
5/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
General disorders
Malaise
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
6.2%
4/64 • From first dose through 28 days after last dose, up to four years and six months.
|
13.3%
2/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
General disorders
Medical device complication
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
General disorders
Mucosal inflammation
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
18.8%
12/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
10.9%
7/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
General disorders
Pain
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
3.1%
2/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
29.7%
19/64 • From first dose through 28 days after last dose, up to four years and six months.
|
13.3%
2/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
General disorders
Thrombosis in device
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
4.7%
3/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
13.3%
2/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
14.1%
9/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
4.7%
3/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
10.9%
7/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
10.9%
7/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
9.4%
6/64 • From first dose through 28 days after last dose, up to four years and six months.
|
20.0%
3/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Alanine aminotransferase
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
18.8%
12/64 • From first dose through 28 days after last dose, up to four years and six months.
|
20.0%
3/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
14.1%
9/64 • From first dose through 28 days after last dose, up to four years and six months.
|
26.7%
4/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
3.1%
2/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
3.1%
2/64 • From first dose through 28 days after last dose, up to four years and six months.
|
13.3%
2/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
6.2%
4/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Red blood cells urine
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
6.2%
4/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
7.8%
5/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
31.2%
20/64 • From first dose through 28 days after last dose, up to four years and six months.
|
46.7%
7/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
6.2%
4/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
7.8%
5/64 • From first dose through 28 days after last dose, up to four years and six months.
|
33.3%
5/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
4/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
9.4%
6/64 • From first dose through 28 days after last dose, up to four years and six months.
|
13.3%
2/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
10.9%
7/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
4.7%
3/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
18.8%
12/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
3.1%
2/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
6.2%
4/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
3.1%
2/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
15.6%
10/64 • From first dose through 28 days after last dose, up to four years and six months.
|
20.0%
3/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
3.1%
2/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
6.2%
4/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
17.2%
11/64 • From first dose through 28 days after last dose, up to four years and six months.
|
20.0%
3/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
9.4%
6/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
28.1%
18/64 • From first dose through 28 days after last dose, up to four years and six months.
|
13.3%
2/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
7.8%
5/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
14.1%
9/64 • From first dose through 28 days after last dose, up to four years and six months.
|
13.3%
2/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
7.8%
5/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
3.1%
2/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
14.1%
9/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
3.1%
2/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
7.8%
5/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
4.7%
3/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
7.8%
5/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
6.2%
4/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
3.1%
2/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Renal and urinary disorders
Ureteric haemorrhage
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
3.1%
2/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
20.3%
13/64 • From first dose through 28 days after last dose, up to four years and six months.
|
20.0%
3/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
50.0%
3/6 • From first dose through 28 days after last dose, up to four years and six months.
|
10.9%
7/64 • From first dose through 28 days after last dose, up to four years and six months.
|
20.0%
3/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
50.0%
3/6 • From first dose through 28 days after last dose, up to four years and six months.
|
7.8%
5/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
6.2%
4/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
6.2%
4/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to four years and six months.
|
3.1%
2/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
18.8%
12/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
13.3%
2/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
4.7%
3/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
10.9%
7/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
1.6%
1/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
3.1%
2/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
15.6%
10/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
6.2%
4/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
3.1%
2/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to four years and six months.
|
4.7%
3/64 • From first dose through 28 days after last dose, up to four years and six months.
|
6.7%
1/15 • From first dose through 28 days after last dose, up to four years and six months.
|
Additional Information
Senior Director, Clinical Operations
Puma Biotechnology, Inc.
Phone: +1 (424) 248-6500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60