Trial Outcomes & Findings for A Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases (NCT NCT03625141)
NCT ID: NCT03625141
Last Updated: 2024-04-11
Results Overview
Intracranial ORR is defined as the percentage of participants with either a complete response (CR) or a partial response (PR) in their intracranial disease based on two consecutive assessments \>= 4 weeks apart. Disease status for this endpoint will be determined by an Independent Review Committee (IRC) in accordance with Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) with modified measurability definition for intracranial lesions (\>= 0.5 cm by MRI) and allowing up to five intracranial target lesions. CR is defined as disappearance of all lesions. PR is defined as \>=30% decrease in tumor burden, in the absence of CR. The primary endpoint is analyzed on the BRAFV600 mutation positive (Cohort 2) only as the Sponsor had discontinued enrolment into Cohort 1. Data for Cohort 1 was not collected nor analyzed for this outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Baseline up to cut of date (approximately 2.5 years)
Results posted on
2024-04-11
Participant Flow
The study was conducted at 21 centers in 7 countries.
A total of 80 participants were enrolled at 21 centers.
Participant milestones
| Measure |
Cohort 1- Cobimetinib and Atezolizumab
Participants with BRAFV600 wild-type disease will be administered cobimetinib on Days 1-21 of each 28-day cycle; and atezolizumab on Days 1 and 15 of each treatment cycle.
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
65
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
65
|
Reasons for withdrawal
| Measure |
Cohort 1- Cobimetinib and Atezolizumab
Participants with BRAFV600 wild-type disease will be administered cobimetinib on Days 1-21 of each 28-day cycle; and atezolizumab on Days 1 and 15 of each treatment cycle.
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Study Terminated By Sponsor
|
1
|
13
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Withdrawal Of Consent
|
0
|
1
|
|
Overall Study
Death
|
11
|
47
|
|
Overall Study
Progressive Disease
|
0
|
2
|
Baseline Characteristics
A Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases
Baseline characteristics by cohort
| Measure |
Cohort 1- Cobimetinib and Atezolizumab
n=15 Participants
Participants with BRAFV600 wild-type disease will be administered cobimetinib on Days 1-21 of each 28-day cycle; and atezolizumab on Days 1 and 15 of each treatment cycle.
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=65 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 Years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
54.4 Years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
55.6 Years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to cut of date (approximately 2.5 years)Population: The evaluable population included all enrolled participants who received study medication and had at least two post-baseline intracranial tumour assessments for response evaluation.
Intracranial ORR is defined as the percentage of participants with either a complete response (CR) or a partial response (PR) in their intracranial disease based on two consecutive assessments \>= 4 weeks apart. Disease status for this endpoint will be determined by an Independent Review Committee (IRC) in accordance with Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) with modified measurability definition for intracranial lesions (\>= 0.5 cm by MRI) and allowing up to five intracranial target lesions. CR is defined as disappearance of all lesions. PR is defined as \>=30% decrease in tumor burden, in the absence of CR. The primary endpoint is analyzed on the BRAFV600 mutation positive (Cohort 2) only as the Sponsor had discontinued enrolment into Cohort 1. Data for Cohort 1 was not collected nor analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=56 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib and Vemurafenib
There were 5 participants in Cohort 2 administered with cobimetinib and vemurafenib only as they dropped out during the run-in period.
|
|---|---|---|---|
|
Intracranial Objective Response Rate (ORR)
|
46.4 Percentage of participants
Interval 32.99 to 60.26
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to cut of date (approximately 2.5 years)Population: The safety population included all participants who received at least one dose of study treatment.
Extracranial ORR, defined as the percentage of participants with either a CR or PR in their extracranial disease based on two consecutive assessments \>=4 weeks apart, as determined by the investigator according to RECIST v1.1.
Outcome measures
| Measure |
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=15 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=65 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib and Vemurafenib
There were 5 participants in Cohort 2 administered with cobimetinib and vemurafenib only as they dropped out during the run-in period.
|
|---|---|---|---|
|
Extracranial ORR
|
20.0 Percentage of participants
Interval 4.33 to 48.09
|
56.9 Percentage of participants
Interval 44.04 to 69.15
|
—
|
SECONDARY outcome
Timeframe: Baseline up to cut of date (approximately 2.5 years)Population: The safety population included all participants who received at least one dose of study treatment.
Overall ORR, defined as the percentage of participants with either a CR or PR in their overall disease (i.e. including intracranial and extracranial disease) based on two consecutive assessments \>= 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. PR was defined as at least a 30 percent (%) decrease in sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Outcome measures
| Measure |
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=15 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=65 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib and Vemurafenib
There were 5 participants in Cohort 2 administered with cobimetinib and vemurafenib only as they dropped out during the run-in period.
|
|---|---|---|---|
|
Overall ORR
|
26.7 Percentage of participants
Interval 7.79 to 55.1
|
52.3 Percentage of participants
Interval 39.54 to 64.85
|
—
|
SECONDARY outcome
Timeframe: Baseline up to cut of date (approximately 2.5 years)Population: The safety population included all participants who received at least one dose of study treatment.
Intracranial, extracranial and overall PFS defined as the time from study treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1.
Outcome measures
| Measure |
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=15 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=65 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib and Vemurafenib
There were 5 participants in Cohort 2 administered with cobimetinib and vemurafenib only as they dropped out during the run-in period.
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
Extracranial
|
4.21 Months
Interval 1.84 to 12.65
|
10.68 Months
Interval 7.85 to 13.67
|
—
|
|
Progression-Free Survival (PFS)
Intracranial
|
2.17 Months
Interval 1.74 to 7.98
|
5.78 Months
Interval 5.36 to 7.43
|
—
|
|
Progression-Free Survival (PFS)
Overall
|
1.81 Months
Interval 1.71 to 3.71
|
5.49 Months
Interval 5.13 to 7.43
|
—
|
SECONDARY outcome
Timeframe: Baseline up to cut of date (approximately 2.5 years)Population: The safety population included all participants who received at least one dose of study treatment.
Intracranial, extracranial and overall DOR, defined as the time from the first occurrence of a documented objective response based on two consecutive assessments ≥ 4 weeks apart to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. This endpoint is analyzed on the BRAFV600 mutation positive (Cohort 2) only as the Sponsor had discontinued enrolment into Cohort 1. Data for Cohort 1 was not collected nor analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=65 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib and Vemurafenib
There were 5 participants in Cohort 2 administered with cobimetinib and vemurafenib only as they dropped out during the run-in period.
|
|---|---|---|---|
|
Duration of Response (DOR)
Intracranial
|
6.7 Months
Interval 5.6 to 9.5
|
—
|
—
|
|
Duration of Response (DOR)
Extracranial
|
11.6 Months
Interval 9.2 to 13.0
|
—
|
—
|
|
Duration of Response (DOR)
Overall
|
7.4 Months
Interval 5.5 to 9.5
|
—
|
—
|
SECONDARY outcome
Timeframe: At 16 weeksPopulation: The safety population included all participants who received at least one dose of study treatment.
Intracranial, extracranial and overall DCR, defined as the percentage of participants with a CR or PR or stable disease (SD) at 16 weeks from study treatment initiation, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. PR was defined as at least a 30 percent (%) decrease in sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD is defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for disease progression. Disease progression is defined as \>=20% increase in tumor burden. This endpoint is analyzed on the BRAFV600 mutation positive (Cohort 2) only as the Sponsor had discontinued enrolment into Cohort 1. Data for Cohort 1 was not collected nor analyzed for this outcome measure.
Outcome measures
| Measure |
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=65 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib and Vemurafenib
There were 5 participants in Cohort 2 administered with cobimetinib and vemurafenib only as they dropped out during the run-in period.
|
|---|---|---|---|
|
Disease Control Rate (DCR)
Intracranial
|
50.8 Percentage of participants
Interval 38.07 to 63.4
|
—
|
—
|
|
Disease Control Rate (DCR)
Extracranial
|
50.8 Percentage of participants
Interval 38.07 to 63.4
|
—
|
—
|
|
Disease Control Rate (DCR)
Overall
|
50.8 Percentage of participants
Interval 38.07 to 63.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 4 years, 4 monthsPopulation: The safety population included all participants who received at least one dose of study treatment.
OS is defined as the time from study treatment initiation to death from any cause.
Outcome measures
| Measure |
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=65 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib and Vemurafenib
There were 5 participants in Cohort 2 administered with cobimetinib and vemurafenib only as they dropped out during the run-in period.
|
|---|---|---|---|
|
Overall Survival (OS)
|
13.40 Months
Interval 10.68 to 16.92
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: The PRO-evaluable population included all participants who received any amount of any study medication (e.g., atezolizumab, cobimetinib, or vemurafenib) and had a baseline and at least one post baseline PRO assessment in the questionnaire of interest (EORTC QLQ-C30 or EORTC QLQBN20).
Time from study treatment initiation to cognitive symptom deterioration, defined as a change (\>= 10 points on a 0-100 scale) on selected scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-BN20) (visual disorder, motor dysfunction, communication deficit, headaches, seizures and drowsiness).
Outcome measures
| Measure |
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=13 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=63 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib and Vemurafenib
There were 5 participants in Cohort 2 administered with cobimetinib and vemurafenib only as they dropped out during the run-in period.
|
|---|---|---|---|
|
Time to Cognitive Symptom Deterioration
Visual Disorder
|
3.75 Months
Interval 1.87 to
Insufficient number of participants with event.
|
2.99 Months
Interval 1.41 to 8.74
|
—
|
|
Time to Cognitive Symptom Deterioration
Motor Dysfunction
|
1.87 Months
Interval 1.08 to 19.84
|
6.70 Months
Interval 3.94 to 13.9
|
—
|
|
Time to Cognitive Symptom Deterioration
Communication Deficit
|
6.44 Months
Interval 2.83 to
Insufficient number of participants with event.
|
13.90 Months
Interval 6.54 to 21.13
|
—
|
|
Time to Cognitive Symptom Deterioration
Headaches
|
NA Months
Interval 1.08 to
Insufficient number of participants with event.
|
10.84 Months
Interval 5.55 to
Insufficient number of participants with event.
|
—
|
|
Time to Cognitive Symptom Deterioration
Seizures
|
8.31 Months
Interval 8.31 to
Insufficient number of participants with event.
|
NA Months
Interval 17.74 to
Insufficient number of participants with event.
|
—
|
|
Time to Cognitive Symptom Deterioration
Drowsiness
|
2.83 Months
Interval 1.08 to
Insufficient number of participants with event.
|
7.16 Months
Interval 1.94 to
Insufficient number of participants with event.
|
—
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: The PRO-evaluable population included all participants who received any amount of any study medication (e.g., atezolizumab, cobimetinib, or vemurafenib) and had a baseline and at least one post baseline PRO assessment in the questionnaire of interest (EORTC QLQ-C30 or EORTC QLQBN20).
Time from study treatment initiation to symptom and function deterioration defined as a change (\>= 10 points on a 0-100 scale) in fatigue, physical functioning, cognitive functioning, or role functioning as measured by the Fatigue, Physical, Cognitive, Role Functioning scales of the EORTC QLQ-C30.
Outcome measures
| Measure |
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=13 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=63 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib and Vemurafenib
There were 5 participants in Cohort 2 administered with cobimetinib and vemurafenib only as they dropped out during the run-in period.
|
|---|---|---|---|
|
Time to Symptom and Function Deterioration
Physical Functioning
|
NA Months
Interval 0.99 to
Insufficient number of participants with event.
|
11.56 Months
Interval 5.55 to
Insufficient number of participants with event.
|
—
|
|
Time to Symptom and Function Deterioration
Cognitive Functioning
|
11.99 Months
Interval 1.91 to
Insufficient number of participants with event.
|
8.25 Months
Interval 5.55 to
Insufficient number of participants with event.
|
—
|
|
Time to Symptom and Function Deterioration
Role Functioning
|
2.83 Months
Interval 1.35 to 6.47
|
4.07 Months
Interval 1.61 to 6.47
|
—
|
|
Time to Symptom and Function Deterioration
Fatigue
|
1.35 Months
Interval 0.95 to
Insufficient number of participants with event.
|
1.45 Months
Interval 1.38 to 6.47
|
—
|
SECONDARY outcome
Timeframe: Baseline up to cut of date (approximately 2.5 years)Population: The PRO-evaluable population included all participants who received any amount of any study medication (e.g., atezolizumab, cobimetinib, or vemurafenib) and had a baseline and at least one post baseline PRO assessment in the questionnaire of interest (EORTC QLQ-C30 or EORTC QLQBN20).
Duration of Stable/Improved HRQoL scores as assessed through use of the two-item Global Health Status (GHS)/HRQoL subscale (Questions 29 and 30) of the EORTC QLQ-C30.
Outcome measures
| Measure |
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=13 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=63 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib and Vemurafenib
There were 5 participants in Cohort 2 administered with cobimetinib and vemurafenib only as they dropped out during the run-in period.
|
|---|---|---|---|
|
Duration of Stable/Improved Health-related Quality of Life (HRQoL) Scores
|
NA Months
Interval 15.21 to
There were an insufficient number of participants with an event.
|
6.14 Months
Interval 3.68 to 10.32
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 4 years, 4 monthsPopulation: The safety population included all participants who received at least one dose of study treatment.
The safety profile of Cobimetinib plus Atezolizumab and Cobimetinib plus Atezolizumab plus Vemurafenib is evaluated in terms of occurrence and severity of AEs. Severity will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)
Outcome measures
| Measure |
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=15 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=60 Participants
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib and Vemurafenib
n=5 Participants
There were 5 participants in Cohort 2 administered with cobimetinib and vemurafenib only as they dropped out during the run-in period.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events
Occurrence
|
15 Participants
|
60 Participants
|
5 Participants
|
|
Percentage of Participants With Adverse Events
Grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Percentage of Participants With Adverse Events
Grade 2
|
3 Participants
|
13 Participants
|
1 Participants
|
|
Percentage of Participants With Adverse Events
Grade 3
|
9 Participants
|
35 Participants
|
2 Participants
|
|
Percentage of Participants With Adverse Events
Grade 4
|
1 Participants
|
10 Participants
|
0 Participants
|
|
Percentage of Participants With Adverse Events
Grade 5
|
1 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Cohort 1- Cobimetinib and Atezolizumab
Serious events: 6 serious events
Other events: 15 other events
Deaths: 11 deaths
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
Serious events: 21 serious events
Other events: 60 other events
Deaths: 47 deaths
Cohort 2 - Cobimetinib and Vemurafenib
Serious events: 5 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Cohort 1- Cobimetinib and Atezolizumab
n=15 participants at risk
Participants with BRAFV600 wild-type disease will be administered cobimetinib on Days 1-21 of each 28-day cycle; and atezolizumab on Days 1 and 15 of each treatment cycle.
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=60 participants at risk
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib and Vemurafenib
n=5 participants at risk
There were 5 participants in Cohort 2 administered with cobimetinib and vemurafenib only as they dropped out during the run-in period.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Cardiac disorders
Cardiac failure
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Eye disorders
Retinal detachment
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
General disorders
Death
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
General disorders
Influenza like illness
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
General disorders
Oedema
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Hepatobiliary disorders
Hepatitis toxic
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Bacterial diarrhoea
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
3.3%
2/60 • Number of events 2 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Septic shock
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Transaminases increased
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Nervous system disorders
Epilepsy
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Nervous system disorders
Limbic encephalitis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Nervous system disorders
Seizure
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 2 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Vascular disorders
Thrombophlebitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
Other adverse events
| Measure |
Cohort 1- Cobimetinib and Atezolizumab
n=15 participants at risk
Participants with BRAFV600 wild-type disease will be administered cobimetinib on Days 1-21 of each 28-day cycle; and atezolizumab on Days 1 and 15 of each treatment cycle.
|
Cohort 2 - Cobimetinib, Atezolizumab and Vemurafenib
n=60 participants at risk
Participants with BRAFV600 mutation-positive disease will be administered cobimetinib, atezolizumab and vemurafenib in 28-day treatment cycles. Treatment includes a 28-day run-in period where participants will receive cobimetinib and vemurafenib only. Upon completion of the 28-day run-in period, atezolizumab will be added to their treatment regimen
|
Cohort 2 - Cobimetinib and Vemurafenib
n=5 participants at risk
There were 5 participants in Cohort 2 administered with cobimetinib and vemurafenib only as they dropped out during the run-in period.
|
|---|---|---|---|
|
Nervous system disorders
Sciatica
|
13.3%
2/15 • Number of events 2 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Psychiatric disorders
Confusional state
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
8.3%
5/60 • Number of events 6 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • Number of events 2 • Baseline up to 4 years, 4 months
|
6.7%
4/60 • Number of events 4 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
6.7%
4/60 • Number of events 4 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.3%
2/15 • Number of events 2 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
10.0%
6/60 • Number of events 6 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
8.3%
5/60 • Number of events 5 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
3.3%
2/60 • Number of events 2 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
26.7%
4/15 • Number of events 9 • Baseline up to 4 years, 4 months
|
30.0%
18/60 • Number of events 21 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 5 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
6.7%
4/60 • Number of events 5 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
18.3%
11/60 • Number of events 16 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
2/15 • Number of events 2 • Baseline up to 4 years, 4 months
|
15.0%
9/60 • Number of events 9 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Blood and lymphatic system disorders
Anaemia
|
26.7%
4/15 • Number of events 5 • Baseline up to 4 years, 4 months
|
18.3%
11/60 • Number of events 11 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Cardiac disorders
Left ventricular dysfunction
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Cardiac disorders
Mitral valve incompetence
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Cardiac disorders
Myocardial infarction
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Endocrine disorders
Hyperthyroidism
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
13.3%
8/60 • Number of events 8 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 5 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Eye disorders
Eye pain
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Eye disorders
Keratitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Eye disorders
Retinal detachment
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
3.3%
2/60 • Number of events 2 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Eye disorders
Serous retinal detachment
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Eye disorders
Serous retinopathy
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
13.3%
8/60 • Number of events 9 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Eye disorders
Uveitis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 4 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
8.3%
5/60 • Number of events 5 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Eye disorders
Visual impairment
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
11.7%
7/60 • Number of events 8 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
8.3%
5/60 • Number of events 6 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
10.0%
6/60 • Number of events 7 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
6/15 • Number of events 17 • Baseline up to 4 years, 4 months
|
48.3%
29/60 • Number of events 60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
6.7%
4/60 • Number of events 4 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
10.0%
6/60 • Number of events 6 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
3.3%
2/60 • Number of events 2 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2 • Baseline up to 4 years, 4 months
|
23.3%
14/60 • Number of events 22 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 4 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
8.3%
5/60 • Number of events 5 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 4 • Baseline up to 4 years, 4 months
|
16.7%
10/60 • Number of events 15 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
General disorders
Asthenia
|
26.7%
4/15 • Number of events 5 • Baseline up to 4 years, 4 months
|
31.7%
19/60 • Number of events 23 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
3.3%
2/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
6.7%
4/60 • Number of events 4 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
General disorders
Malaise
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
General disorders
Mass
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
General disorders
Mucosal inflammation
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
10.0%
6/60 • Number of events 12 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
General disorders
Oedema peripheral
|
13.3%
2/15 • Number of events 3 • Baseline up to 4 years, 4 months
|
13.3%
8/60 • Number of events 9 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
General disorders
Pyrexia
|
20.0%
3/15 • Number of events 5 • Baseline up to 4 years, 4 months
|
43.3%
26/60 • Number of events 56 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
General disorders
Xerosis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
COVID-19
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
6.7%
4/60 • Number of events 4 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Fungal skin infection
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Furuncle
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Hordeolum
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Influenza
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Rash pustular
|
13.3%
2/15 • Number of events 2 • Baseline up to 4 years, 4 months
|
3.3%
2/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
6.7%
4/60 • Number of events 5 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
6.7%
4/60 • Number of events 9 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
21.7%
13/60 • Number of events 26 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Amylase increased
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
31.7%
19/60 • Number of events 27 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
2/15 • Number of events 2 • Baseline up to 4 years, 4 months
|
23.3%
14/60 • Number of events 21 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
18.3%
11/60 • Number of events 13 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 4 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Blood creatine phosphokinase increased
|
13.3%
2/15 • Number of events 31 • Baseline up to 4 years, 4 months
|
46.7%
28/60 • Number of events 78 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Blood creatinine increased
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
15.0%
9/60 • Number of events 12 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
8.3%
5/60 • Number of events 5 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Blood magnesium decreased
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Ejection fraction decreased
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Lipase increased
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
38.3%
23/60 • Number of events 45 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Thyroxine free increased
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Transaminases increased
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
6.7%
4/60 • Number of events 5 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Tri-iodothyronine free decreased
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Metabolism and nutrition disorders
Cell death
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
8.3%
5/60 • Number of events 5 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
11.7%
7/60 • Number of events 11 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.3%
2/15 • Number of events 2 • Baseline up to 4 years, 4 months
|
3.3%
2/60 • Number of events 2 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
10.0%
6/60 • Number of events 6 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Metabolism and nutrition disorders
Iron deficiency
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
6.7%
4/60 • Number of events 4 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • Number of events 2 • Baseline up to 4 years, 4 months
|
31.7%
19/60 • Number of events 24 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
10.0%
6/60 • Number of events 6 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
18.3%
11/60 • Number of events 16 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
6.7%
4/60 • Number of events 4 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
3.3%
2/60 • Number of events 2 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Nervous system disorders
Dysgeusia
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
10.0%
6/60 • Number of events 6 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 6 • Baseline up to 4 years, 4 months
|
13.3%
8/60 • Number of events 13 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
33.3%
20/60 • Number of events 29 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.3%
2/15 • Number of events 2 • Baseline up to 4 years, 4 months
|
28.3%
17/60 • Number of events 20 • Baseline up to 4 years, 4 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Scab
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
6.7%
4/60 • Number of events 4 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Vascular disorders
Deep vein thrombosis
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Vascular disorders
Hypertension
|
13.3%
2/15 • Number of events 2 • Baseline up to 4 years, 4 months
|
16.7%
10/60 • Number of events 12 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Vascular disorders
Lymphoedema
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Immune system disorders
Contrast media allergy
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Folliculitis
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 3 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
1.7%
1/60 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/15 • Baseline up to 4 years, 4 months
|
5.0%
3/60 • Number of events 4 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • Baseline up to 4 years, 4 months
|
0.00%
0/60 • Baseline up to 4 years, 4 months
|
0.00%
0/5 • Baseline up to 4 years, 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER