Trial Outcomes & Findings for An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol (NCT NCT01739764)
NCT ID: NCT01739764
Last Updated: 2021-01-07
Results Overview
Dose Intensity was defined as (total actual doses taken/total planned doses) \*100, where total planned doses = prescribed doses \* planned days on treatment, where planned days on treatment were defined as the interval between date of first dose and date of last dose.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
215 participants
Primary outcome timeframe
Baseline up to a maximum of 7 years.
Results posted on
2021-01-07
Participant Flow
The study was conducted at 82 centers in 24 countries.
215 participants were enrolled into this OLE study and were included in the Safety population.
Participant milestones
| Measure |
Vemurafenib 480mg BID
Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Vemurafenib 720mg BID
Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Vemurafenib 960mg BID
Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
40
|
146
|
|
Overall Study
COMPLETED
|
3
|
4
|
20
|
|
Overall Study
NOT COMPLETED
|
26
|
36
|
126
|
Reasons for withdrawal
| Measure |
Vemurafenib 480mg BID
Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Vemurafenib 720mg BID
Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Vemurafenib 960mg BID
Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
4
|
|
Overall Study
Death
|
4
|
6
|
38
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
5
|
|
Overall Study
Non-Compliance
|
0
|
0
|
1
|
|
Overall Study
Multiple Reasons
|
3
|
2
|
3
|
|
Overall Study
Physician Decision
|
2
|
2
|
4
|
|
Overall Study
Progressive Disease
|
3
|
5
|
16
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
|
Overall Study
Study Terminated by Sponsor
|
8
|
13
|
26
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
27
|
Baseline Characteristics
An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
Baseline characteristics by cohort
| Measure |
Vemurafenib 480mg BID
n=29 Participants
Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Vemurafenib 720mg BID
n=40 Participants
Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Vemurafenib 960mg BID
n=146 Participants
Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.4 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
60.6 Years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
52.3 Years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
54.9 Years
STANDARD_DEVIATION 13.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
198 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to a maximum of 7 years.Population: The Safety-evaluable population was defined as all participants who received at least one dose of study medication. Please note that for this Outcome Measure, one participant who received 960 mg BID of Vemurafenib had no treatment end date indicated and was excluded from the calculation of study treatment exposure summaries.
Dose Intensity was defined as (total actual doses taken/total planned doses) \*100, where total planned doses = prescribed doses \* planned days on treatment, where planned days on treatment were defined as the interval between date of first dose and date of last dose.
Outcome measures
| Measure |
Vemurafenib 480mg BID
n=29 Participants
Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Vemurafenib 720mg BID
n=40 Participants
Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Vemurafenib 960mg BID
n=145 Participants
Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
|---|---|---|---|
|
Dose Intensity of Vemurafenib
|
95.3 Percentage of Planned Dose
Standard Deviation 8.1
|
92.9 Percentage of Planned Dose
Standard Deviation 12.1
|
94.5 Percentage of Planned Dose
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).Population: The Safety-evaluable population was defined as all participants who received at least one dose of study medication.
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events. Reported are the Percentage of Participants with AEs and Serious Adverse Events (SAEs).
Outcome measures
| Measure |
Vemurafenib 480mg BID
n=29 Participants
Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Vemurafenib 720mg BID
n=40 Participants
Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Vemurafenib 960mg BID
n=146 Participants
Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
AEs
|
93.1 Percentage of Participants
|
92.5 Percentage of Participants
|
93.2 Percentage of Participants
|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAEs
|
48.3 Percentage of Participants
|
37.5 Percentage of Participants
|
19.9 Percentage of Participants
|
Adverse Events
Vemurafenib 480mg BID
Serious events: 14 serious events
Other events: 21 other events
Deaths: 4 deaths
Vemurafenib 720mg BID
Serious events: 15 serious events
Other events: 29 other events
Deaths: 6 deaths
Vemurafenib 960mg BID
Serious events: 29 serious events
Other events: 119 other events
Deaths: 38 deaths
Serious adverse events
| Measure |
Vemurafenib 480mg BID
n=29 participants at risk
Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Vemurafenib 720mg BID
n=40 participants at risk
Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Vemurafenib 960mg BID
n=146 participants at risk
Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.1%
3/146 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Eye disorders
CATARACT NUCLEAR
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Eye disorders
PAROPHTHALMIA
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.1%
3/146 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
DIVERTICULAR PERFORATION
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
HAEMOPERITONEUM
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
OESOPHAGEAL STENOSIS
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
PANCREATITIS
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
General disorders
ASTHENIA
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
General disorders
DEATH
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
General disorders
FATIGUE
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
General disorders
PYREXIA
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Hepatobiliary disorders
JAUNDICE
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
MENINGITIS
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
PNEUMONIA
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
SINUSITIS BACTERIAL
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Injury, poisoning and procedural complications
TRACHEAL HAEMORRHAGE
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Musculoskeletal and connective tissue disorders
MYOPATHY TOXIC
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN NEOPLASM BENIGN
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CEREBRAL HAEMANGIOMA
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC CANCER
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE DUCTAL BREAST CARCINOMA
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC MALIGNANT MELANOMA
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 4 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
3.4%
1/29 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Nervous system disorders
FACIAL PARALYSIS
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Nervous system disorders
SEIZURE
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Psychiatric disorders
ANXIETY DISORDER
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
3.4%
1/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
3.4%
1/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Surgical and medical procedures
TRACHEAL RESECTION
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
Other adverse events
| Measure |
Vemurafenib 480mg BID
n=29 participants at risk
Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Vemurafenib 720mg BID
n=40 participants at risk
Participants received oral vemurafenib at 720 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
Vemurafenib 960mg BID
n=146 participants at risk
Participants received oral vemurafenib at 960 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
12.5%
5/40 • Number of events 6 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
8.9%
13/146 • Number of events 18 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
7.5%
3/40 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Eye disorders
GLAUCOMA
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Eye disorders
UVEITIS
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 5 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.1%
3/146 • Number of events 4 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Eye disorders
VISION BLURRED
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
10.3%
3/29 • Number of events 6 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
10.0%
4/40 • Number of events 4 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.7%
4/146 • Number of events 4 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
1.4%
2/146 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
CONSTIPATION
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
4.1%
6/146 • Number of events 7 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
DIARRHOEA
|
10.3%
3/29 • Number of events 6 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
7.5%
3/40 • Number of events 5 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
11.0%
16/146 • Number of events 18 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
DYSPEPSIA
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
7.5%
3/40 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.5%
8/146 • Number of events 8 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
DYSPHAGIA
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
1.4%
2/146 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
NAUSEA
|
13.8%
4/29 • Number of events 4 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
20.0%
8/40 • Number of events 8 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
11.0%
16/146 • Number of events 22 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Gastrointestinal disorders
VOMITING
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
10.0%
4/40 • Number of events 5 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
8.2%
12/146 • Number of events 13 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
General disorders
ASTHENIA
|
10.3%
3/29 • Number of events 4 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
12.5%
5/40 • Number of events 5 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.1%
3/146 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
General disorders
FATIGUE
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
12.5%
5/40 • Number of events 5 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
19.2%
28/146 • Number of events 33 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
3.4%
5/146 • Number of events 6 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
General disorders
PYREXIA
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
6.2%
9/146 • Number of events 11 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
CHORIORETINITIS
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
6.8%
10/146 • Number of events 10 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
PNEUMONIA
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
7.5%
3/40 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
1.4%
2/146 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.9%
2/29 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
4.1%
6/146 • Number of events 7 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
10.3%
3/29 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
10.0%
4/40 • Number of events 5 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Injury, poisoning and procedural complications
SUNBURN
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
4.1%
6/146 • Number of events 8 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.1%
3/146 • Number of events 4 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
10.0%
4/40 • Number of events 9 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.5%
8/146 • Number of events 8 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.68%
1/146 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Investigations
BLOOD CREATININE INCREASED
|
3.4%
1/29 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
7.5%
3/40 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.5%
8/146 • Number of events 10 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
4.8%
7/146 • Number of events 11 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Investigations
WEIGHT DECREASED
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
6.8%
10/146 • Number of events 10 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
7.5%
3/40 • Number of events 5 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
13.0%
19/146 • Number of events 24 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/146 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
13.8%
4/29 • Number of events 4 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
25.0%
10/40 • Number of events 15 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
20.5%
30/146 • Number of events 41 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.4%
1/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
6.2%
9/146 • Number of events 9 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
1.4%
2/146 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
4.1%
6/146 • Number of events 6 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
4.8%
7/146 • Number of events 12 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 4 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.1%
3/146 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
6.9%
2/29 • Number of events 4 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.7%
4/146 • Number of events 5 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
11.0%
16/146 • Number of events 24 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
4.8%
7/146 • Number of events 13 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Nervous system disorders
DIZZINESS
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
7.5%
3/40 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
1.4%
2/146 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
10.0%
4/40 • Number of events 4 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
10.3%
15/146 • Number of events 15 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
0.00%
0/40 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
1.4%
2/146 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
6.8%
10/146 • Number of events 10 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
7.5%
3/40 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
4.8%
7/146 • Number of events 12 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
14.4%
21/146 • Number of events 21 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Skin and subcutaneous tissue disorders
DERMAL CYST
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
3.4%
5/146 • Number of events 5 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
1.4%
2/146 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/29 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
12.5%
5/40 • Number of events 5 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
6.2%
9/146 • Number of events 10 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
10.3%
3/29 • Number of events 5 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
4.8%
7/146 • Number of events 13 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Skin and subcutaneous tissue disorders
HYPERKERATOSIS
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
7.5%
3/40 • Number of events 4 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
13.7%
20/146 • Number of events 21 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
10.0%
4/40 • Number of events 4 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
8.2%
12/146 • Number of events 13 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Skin and subcutaneous tissue disorders
PANNICULITIS
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.1%
3/146 • Number of events 10 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.0%
2/40 • Number of events 4 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
15.1%
22/146 • Number of events 32 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
3.4%
1/29 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
7.5%
3/40 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
8.9%
13/146 • Number of events 15 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Skin and subcutaneous tissue disorders
RASH
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
2.5%
1/40 • Number of events 1 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
9.6%
14/146 • Number of events 16 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
|
Vascular disorders
HYPERTENSION
|
6.9%
2/29 • Number of events 2 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
7.5%
3/40 • Number of events 3 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
5.5%
8/146 • Number of events 8 • Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
|
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