Trial Outcomes & Findings for Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer (NCT NCT01902173)
NCT ID: NCT01902173
Last Updated: 2025-01-14
Results Overview
MTD was evaluated by testing increasing doses up to 75 mg once a day, given in combination with dabrafenib dosed at 150 mg twice daily. MTD reflects the highest dose that did not cause a DLT. DLTs were defined as treatment regimen related: febrile neutropenia; Grade 4 neutropenia lasting more than 7 days; Grade 4 platelet count decrease; Grade 3-4 rash, fever, or hyperglycemia \> 14 days, e) Grade 3-4 non-hematologic adverse events lasting greater than 7 days. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Every 2 weeks during days 1-56 of treatment.
Results posted on
2025-01-14
Participant Flow
27 participants were enrolled, however 1 participant on the Dabrafenib + GSK2141795 75 mg arm and 1 participant on the Dabrafenib + Trametinib 1.5mg + GSK2141795 25mg were found to be ineligible. Furthermore, 3 participants on the Dabrafenib + GSK2141795 75 mg arm did not receive protocol treatment were not evaluable for any study endpoint.
Participant milestones
| Measure |
Dabrafenib + GSK2141795 50 mg
Doublet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily and 50 mg of GSK2141795 once daily.
|
Dabrafenib + GSK2141795 75 mg
Doublet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily and 75 mg of GSK2141795 once daily.
|
Dabrafenib + Trametinib 1.5mg + GSK2141795 25mg
Triplet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 25mg of GSK2141795 once daily.
|
Dabrafenib + Trametinib 1.5mg + GSK2141795 50mg
Triplet regimen cohort 2: participants were given 150mg of dabrafenib twice daily, 1.5mg of trametinib and 50mg of GSK2141795 once daily.
|
Dabrafenib + Trametinib 1.5mg + GSK2141795 75mg
Triplet regimen cohort 3: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 75mg of GSK2141795 once daily.
|
Dabrafenib + Trametinib 2.0mg + GSK2141795 75mg
Triplet regimen cohort 4: participants were given 150 mg of dabrafenib twice daily, 2 mg of trametinib and 75 mg of GSK2141795 once daily.
|
|---|---|---|---|---|---|---|
|
Phase 1 Doublet Regimen Cohort 1
STARTED
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Doublet Regimen Cohort 1
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Doublet Regimen Cohort 1
NOT COMPLETED
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Doublet Regimen Cohort 2
STARTED
|
0
|
9
|
0
|
0
|
0
|
0
|
|
Phase 1 Doublet Regimen Cohort 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Doublet Regimen Cohort 2
NOT COMPLETED
|
0
|
9
|
0
|
0
|
0
|
0
|
|
Phase 1 Triplet Regimen Cohort 1
STARTED
|
0
|
0
|
4
|
0
|
0
|
0
|
|
Phase 1 Triplet Regimen Cohort 1
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Triplet Regimen Cohort 1
NOT COMPLETED
|
0
|
0
|
4
|
0
|
0
|
0
|
|
Phase 1 Triplet Regimen Cohort 2
STARTED
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Phase 1 Triplet Regimen Cohort 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Triplet Regimen Cohort 2
NOT COMPLETED
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Phase 1 Triplet Regimen Cohort 3
STARTED
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Phase 1 Triplet Regimen Cohort 3
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Triplet Regimen Cohort 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Phase 1 Triplet Regimen Cohort 4
STARTED
|
0
|
0
|
0
|
0
|
0
|
5
|
|
Phase 1 Triplet Regimen Cohort 4
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Triplet Regimen Cohort 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
5
|
|
Phase II
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase II
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dabrafenib + GSK2141795 50 mg
Doublet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily and 50 mg of GSK2141795 once daily.
|
Dabrafenib + GSK2141795 75 mg
Doublet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily and 75 mg of GSK2141795 once daily.
|
Dabrafenib + Trametinib 1.5mg + GSK2141795 25mg
Triplet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 25mg of GSK2141795 once daily.
|
Dabrafenib + Trametinib 1.5mg + GSK2141795 50mg
Triplet regimen cohort 2: participants were given 150mg of dabrafenib twice daily, 1.5mg of trametinib and 50mg of GSK2141795 once daily.
|
Dabrafenib + Trametinib 1.5mg + GSK2141795 75mg
Triplet regimen cohort 3: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 75mg of GSK2141795 once daily.
|
Dabrafenib + Trametinib 2.0mg + GSK2141795 75mg
Triplet regimen cohort 4: participants were given 150 mg of dabrafenib twice daily, 2 mg of trametinib and 75 mg of GSK2141795 once daily.
|
|---|---|---|---|---|---|---|
|
Phase 1 Doublet Regimen Cohort 1
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Doublet Regimen Cohort 1
Progression/relapse
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Doublet Regimen Cohort 2
Progression/relapse
|
0
|
5
|
0
|
0
|
0
|
0
|
|
Phase 1 Doublet Regimen Cohort 2
Ineligible
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Phase 1 Doublet Regimen Cohort 2
No treated
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Phase 1 Triplet Regimen Cohort 1
Progression/relapse
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Phase 1 Triplet Regimen Cohort 1
Ineligible
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Phase 1 Triplet Regimen Cohort 2
Ongoing treatment
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Phase 1 Triplet Regimen Cohort 2
Progression/relapse
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Phase 1 Triplet Regimen Cohort 3
Ongoing
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Phase 1 Triplet Regimen Cohort 3
Progression/relapse
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Phase 1 Triplet Regimen Cohort 4
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase 1 Triplet Regimen Cohort 4
Progression/relapse
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Phase 1 Triplet Regimen Cohort 4
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer
Baseline characteristics by cohort
| Measure |
Dabrafenib + GSK2141795 50 mg
n=3 Participants
Doublet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily and 50 mg of GSK2141795 once daily.
|
Dabrafenib + GSK2141795 75 mg
n=5 Participants
Doublet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily and 75 mg of GSK2141795 once daily
|
Dabrafenib + Trametinib 1.5mg + GSK2141795 25mg
n=3 Participants
Triplet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 25mg of GSK2141795 once daily.
|
Dabrafenib + Trametinib 1.5mg + GSK2141795 50mg
n=3 Participants
Triplet regimen cohort 2: participants were given 150mg of dabrafenib twice daily, 1.5mg of trametinib and 50mg of GSK2141795 once daily
|
Dabrafenib + Trametinib 1.5mg + GSK2141795 75mg
n=3 Participants
Triplet regimen cohort 3: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 75mg of GSK2141795 once daily.
|
Dabrafenib + Trametinib 2.0mg + GSK2141795 75mg
n=5 Participants
Triplet regimen cohort 4: participants were given 150 mg of dabrafenib twice daily, 2 mg of trametinib and 75 mg of GSK2141795 once daily.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.7 years
n=5 Participants
|
64.4 years
n=7 Participants
|
63.9 years
n=5 Participants
|
40.1 years
n=4 Participants
|
56.7 years
n=21 Participants
|
50.4 years
n=8 Participants
|
58.1 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Prior BRAF inhibitor
Yes
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Prior BRAF inhibitor
No
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Prior BRAF inhibitor
Not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Type of cancer
Melanoma
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Type of cancer
Lung
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Type of cancer
Thyroid
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Every 2 weeks during days 1-56 of treatment.Population: Eligible, analyzable and evaluable participants that were assessed for DLT. In the Dabrafenib + GSK2141795 75 mg arm, 1 participant was ineligible, 3 participants were not analyzable, and 1 participant did not satisfy protocol-specified criteria for DLT evaluation. These patients were excluded from DLT analysis.
MTD was evaluated by testing increasing doses up to 75 mg once a day, given in combination with dabrafenib dosed at 150 mg twice daily. MTD reflects the highest dose that did not cause a DLT. DLTs were defined as treatment regimen related: febrile neutropenia; Grade 4 neutropenia lasting more than 7 days; Grade 4 platelet count decrease; Grade 3-4 rash, fever, or hyperglycemia \> 14 days, e) Grade 3-4 non-hematologic adverse events lasting greater than 7 days. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
Phase 1 Doublet Regimen
n=7 Participants
All analyzable patients who experienced a dose limiting toxicity OR at least received GSK2141795 for 11 days in Cycle 1 and dabrafenib for 28 days in cycles 1 and 2 OR at least received GSK2141795 for 11 days in Cycle 1 and 50% of dabrafenib in Cycle 1
|
|---|---|
|
Maximum-tolerated Dose (MTD) of Akt Inhibitor GSK2141795 in Combination With Dabrafenib.
|
75 mg
|
PRIMARY outcome
Timeframe: Every 2 weeks during days 1-56 of treatment.Population: Eligible and evaluable participants that were assessed for DLT. 1 participant in the Dabrafenib + Trametinib 1.5 mg + GSK2141795 25 mg was not eligible. 1 participant in the Dabrafenib + Trametinib 2.0 mg + GSK2141795 75 mg arm did not satisfy protocol-specified criteria for DLT evaluation and was thus excluded.
MTD was evaluated by testing increasing doses up to 75 mg once a day, given in combination with dabrafenib dosed at 150 mg twice daily and trametinib at either 1.5 mg or 2 mg once a day. MTD reflects the highest dose that did not cause a dose-limiting toxicity (DLT). DLTs were defined as treatment regimen related: febrile neutropenia; Grade 4 neutropenia lasting more than 7 days; Grade 4 platelet count decrease; Grade 3-4 rash, fever, or hyperglycemia \> 14 days, e) Grade 3-4 non-hematologic adverse events lasting greater than 7 days. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Note: MTD for the triplet regimen could not be determined due to the end of supply of the study drug. Number reported is the maximum dose of GSK2141795 that was assessed in combination with 150 mg Dabrafenib and 2 mg trametinib.
Outcome measures
| Measure |
Phase 1 Doublet Regimen
n=13 Participants
All analyzable patients who experienced a dose limiting toxicity OR at least received GSK2141795 for 11 days in Cycle 1 and dabrafenib for 28 days in cycles 1 and 2 OR at least received GSK2141795 for 11 days in Cycle 1 and 50% of dabrafenib in Cycle 1
|
|---|---|
|
Maximum-tolerated Dose (MTD) of Akt Inhibitor GSK2141795 in Combination With Dabrafenib and Trametinib.
|
75 mg
|
PRIMARY outcome
Timeframe: Disease assessments every 8 weeks for up to 3 yearsPopulation: No participants were enrolled to Phase II portion due to the end of the supply of GSK2141795
All measurable lesions up to a maximum of 2 lesions per organ 5 lesions in total, representative of all involved organs, were identified as target lesions at baseline. All other lesions (or sites of disease) were identified as non-target lesions. Complete Response (CR): Complete disappearance of all target and nontarget lesions. No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to \< 1.0 cm. Partial Response (PR): \<= 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Unconfirmed CR: One objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR: One objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Disease assessments every 8 weeks for up to 3 yearsPopulation: No participants were enrolled to Phase II portion due to the end of the supply of GSK2141795
All measurable lesions up to a maximum of 2 lesions per organ 5 lesions in total, representative of all involved organs, were identified as target lesions at baseline. All other lesions (or sites of disease) were identified as non-target lesions. Complete Response (CR): Complete disappearance of all target and nontarget lesions. No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to \< 1.0 cm. Partial Response (PR): \<= 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Unconfirmed CR: One objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR: One objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of registration to date of death due to any cause, assessed up to 3 yearsPopulation: No participants were enrolled to Phase II portion due to the end of the supply of GSK2141795
Estimated with 95% confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of registration to date of death due to any cause, assessed up to 3 yearsPopulation: No participants were enrolled to Phase II portion due to the end of the supply of GSK2141795
Estimated with 95% confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 yearsPopulation: No participants were enrolled to Phase II portion due to the end of the supply of GSK2141795
Estimated with 95% confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 yearsPopulation: No participants were enrolled to Phase II portion due to the end of the supply of GSK2141795
Estimated with 95% confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: No participants were enrolled to the Phase II portion due to the end of the supply of GSK2141795
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, pre-dose and 1, 2, 4, and 8 hours on day 15, and pre-dose day 29Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsFor binary markers, the prevalence will be able to be estimated and exact binomial confidence interval will be calculated. The association between these categorical markers and clinical outcomes will be explored in a preliminary manner, using Fisher's exact test to compare response and a logrank test to compare Kaplan-Meier estimates of overall survival and progression free survival between marker positive and marker negative groups.
Outcome measures
Outcome data not reported
Adverse Events
Dabrafenib + GSK2141795 50 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Dabrafenib + GSK2141795 75 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths
Dabrafenib + Trametinib 1.5 mg + GSK2141795 25 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Dabrafenib + Trametinib 1.5 mg + GSK2141795 50 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Dabrafenib + Trametinib 1.5 mg + GSK2141795 75 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Dabrafenib + Trametinib 2 mg + GSK2141795 75 mg
Serious events: 5 serious events
Other events: 5 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Dabrafenib + GSK2141795 50 mg
n=3 participants at risk
Doublet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily and 50 mg of GK2141795 once daily.
|
Dabrafenib + GSK2141795 75 mg
n=5 participants at risk
Doublet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily and 75 mg of GK2141795 once daily.
|
Dabrafenib + Trametinib 1.5 mg + GSK2141795 25 mg
n=3 participants at risk
Triplet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 25 mg of GK2141795 once daily.
|
Dabrafenib + Trametinib 1.5 mg + GSK2141795 50 mg
n=3 participants at risk
Triplet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 50 mg of GK2141795 once daily.
|
Dabrafenib + Trametinib 1.5 mg + GSK2141795 75 mg
n=3 participants at risk
Triplet regimen cohort 3: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 75 mg of GK2141795 once daily.
|
Dabrafenib + Trametinib 2 mg + GSK2141795 75 mg
n=5 participants at risk
Triplet regimen cohort 4: participants were given 150 mg of dabrafenib twice daily, 2 mg of trametinib and 75 mg of GK2141795 once daily.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 3 years
|
40.0%
2/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
General disorders
Fatigue
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
General disorders
Fever
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
60.0%
3/5 • 3 years
|
|
General disorders
General disorders and admin site conditions - Other
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
General disorders
Localized edema
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
Other adverse events
| Measure |
Dabrafenib + GSK2141795 50 mg
n=3 participants at risk
Doublet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily and 50 mg of GK2141795 once daily.
|
Dabrafenib + GSK2141795 75 mg
n=5 participants at risk
Doublet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily and 75 mg of GK2141795 once daily.
|
Dabrafenib + Trametinib 1.5 mg + GSK2141795 25 mg
n=3 participants at risk
Triplet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 25 mg of GK2141795 once daily.
|
Dabrafenib + Trametinib 1.5 mg + GSK2141795 50 mg
n=3 participants at risk
Triplet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 50 mg of GK2141795 once daily.
|
Dabrafenib + Trametinib 1.5 mg + GSK2141795 75 mg
n=3 participants at risk
Triplet regimen cohort 3: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 75 mg of GK2141795 once daily.
|
Dabrafenib + Trametinib 2 mg + GSK2141795 75 mg
n=5 participants at risk
Triplet regimen cohort 4: participants were given 150 mg of dabrafenib twice daily, 2 mg of trametinib and 75 mg of GK2141795 once daily.
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
66.7%
2/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • 3 years
|
60.0%
3/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Cardiac disorders
Cardiac disorders-Other
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders - Other
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Eye disorders
Eye disorders-Other
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Eye disorders
Flashing lights
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Eye disorders
Uveitis
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
66.7%
2/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
66.7%
2/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
60.0%
3/5 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • 3 years
|
40.0%
2/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
66.7%
2/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • 3 years
|
60.0%
3/5 • 3 years
|
33.3%
1/3 • 3 years
|
33.3%
1/3 • 3 years
|
100.0%
3/3 • 3 years
|
60.0%
3/5 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • 3 years
|
40.0%
2/5 • 3 years
|
66.7%
2/3 • 3 years
|
66.7%
2/3 • 3 years
|
33.3%
1/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
General disorders
Chills
|
33.3%
1/3 • 3 years
|
40.0%
2/5 • 3 years
|
66.7%
2/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
General disorders
Edema limbs
|
66.7%
2/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
General disorders
Fatigue
|
100.0%
3/3 • 3 years
|
60.0%
3/5 • 3 years
|
100.0%
3/3 • 3 years
|
33.3%
1/3 • 3 years
|
33.3%
1/3 • 3 years
|
60.0%
3/5 • 3 years
|
|
General disorders
Fever
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
66.7%
2/3 • 3 years
|
66.7%
2/3 • 3 years
|
33.3%
1/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
General disorders
Flu like symptoms
|
33.3%
1/3 • 3 years
|
40.0%
2/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
General disorders
Gait disturbance
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
General disorders
General disorders and admin site conditions - Other
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
General disorders
Irritability
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
General disorders
Malaise
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
General disorders
Pain
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Infections and infestations
Bronchial infection
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Infections and infestations
Infections and infestations-Other
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Injury, poisoning and procedural complications
Injury, poison and procedural complications - Other
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
33.3%
1/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
33.3%
1/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Investigations
INR increased
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Investigations
Investigations-Other
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Investigations
Lipase increased
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • 3 years
|
20.0%
1/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
60.0%
3/5 • 3 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Investigations
Weight loss
|
66.7%
2/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
60.0%
3/5 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • 3 years
|
60.0%
3/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
2/3 • 3 years
|
40.0%
2/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
66.7%
2/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 3 years
|
40.0%
2/5 • 3 years
|
0.00%
0/3 • 3 years
|
66.7%
2/3 • 3 years
|
0.00%
0/3 • 3 years
|
60.0%
3/5 • 3 years
|
|
Nervous system disorders
Nervous system disorders-Other
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Psychiatric disorders
Psychiatric disorders-Other
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
0.00%
0/3 • 3 years
|
40.0%
2/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • 3 years
|
40.0%
2/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
66.7%
2/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
66.7%
2/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • 3 years
|
40.0%
2/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
60.0%
3/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
40.0%
2/5 • 3 years
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
20.0%
1/5 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Vascular disorders
Vascular disorders-Other
|
33.3%
1/3 • 3 years
|
0.00%
0/5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/5 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60