Trial Outcomes & Findings for Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma (NCT NCT01693068)

NCT ID: NCT01693068

Last Updated: 2018-01-05

Results Overview

PFS was defined as the duration (in weeks) from randomization until the first progressive disease (PD) observation as assessed by the Investigator according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, or death due to any cause when death occurred within 12 weeks after the last tumor assessment (otherwise censored), whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

194 participants

Primary outcome timeframe

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015)

Results posted on

2018-01-05

Participant Flow

First/last subject (informed consent): 05 December 2012/04 June 2014. Cut-off date: 04 July 2015. Last subject last visit: 24 October 2016.

A total of 194 subjects were randomized in trial. Data presented based on the cut-off date of 04 July 2015.

Participant milestones

Participant milestones
Measure
Dacarbazine
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
Subjects received pimasertib orally as monotherapy at a dose of 60 milligram (mg) twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
Randomization Period
STARTED
64
130
0
Randomization Period
Treated
61
130
0
Randomization Period
COMPLETED
62
125
0
Randomization Period
NOT COMPLETED
2
5
0
Cross-over (Dacarbazine To Pimasertib)
STARTED
0
0
41
Cross-over (Dacarbazine To Pimasertib)
Treated
0
0
41
Cross-over (Dacarbazine To Pimasertib)
COMPLETED
0
0
40
Cross-over (Dacarbazine To Pimasertib)
NOT COMPLETED
0
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Dacarbazine
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
Subjects received pimasertib orally as monotherapy at a dose of 60 milligram (mg) twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
Randomization Period
On-study
2
5
0
Cross-over (Dacarbazine To Pimasertib)
On-study
0
0
1

Baseline Characteristics

Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dacarbazine
n=64 Participants
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
n=130 Participants
Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Total
n=194 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
36 Participants
n=5 Participants
65 Participants
n=7 Participants
101 Participants
n=5 Participants
Age, Categorical
>=65 years
28 Participants
n=5 Participants
65 Participants
n=7 Participants
93 Participants
n=5 Participants
Sex: Female, Male
Female
28 Participants
n=5 Participants
62 Participants
n=7 Participants
90 Participants
n=5 Participants
Sex: Female, Male
Male
36 Participants
n=5 Participants
68 Participants
n=7 Participants
104 Participants
n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015)

Population: ITT analysis set included all subjects who were randomized to trial treatment.

PFS was defined as the duration (in weeks) from randomization until the first progressive disease (PD) observation as assessed by the Investigator according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, or death due to any cause when death occurred within 12 weeks after the last tumor assessment (otherwise censored), whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure
Dacarbazine
n=64 Participants
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
n=130 Participants
Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
Progression Free Survival (PFS)
6.86 weeks
Interval 6.0 to 12.14
13.00 weeks
Interval 12.29 to 17.71

SECONDARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015)

Population: ITT analysis set included all subjects who were randomized to trial treatment.

ORR was defined as the percentage of subjects with complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters along with absence of new lesions and disease progression in non-target lesions.

Outcome measures

Outcome measures
Measure
Dacarbazine
n=64 Participants
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
n=130 Participants
Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
Objective Response Rate (ORR)
14.1 percentage of subjects
Interval 6.6 to 25.0
26.9 percentage of subjects
Interval 19.5 to 35.4

SECONDARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015)

Population: ITT analysis set included all subjects who were randomized to trial treatment.

DCR was defined as the percentage of subjects with CR, PR, or stable disease (SD) for greater than (\>) 3 months assessed by investigator according to RECIST version 1.1. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than \<10 mm. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters along with absence of new lesions and disease progression in non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure
Dacarbazine
n=64 Participants
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
n=130 Participants
Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
Disease Control Rate (DCR)
15.6 percentage of subjects
Interval 7.8 to 26.9
33.1 percentage of subjects
Interval 25.1 to 41.9

SECONDARY outcome

Timeframe: 6 months

Population: ITT analysis set included all subjects who were randomized to trial treatment.

PFS was defined as the duration (in weeks) from randomization until the first progressive disease (PD) observation as assessed by the Investigator according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, or death due to any cause when death occurred within 12 weeks after the last tumor assessment, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions. Percentage of Subjects with PFS at 6 Months were reported.

Outcome measures

Outcome measures
Measure
Dacarbazine
n=64 Participants
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
n=130 Participants
Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
Percentage of Subjects With Progression-free Survival (PFS) at 6 Months
9.4 percentage of subjects
Interval 3.6 to 18.6
17.3 percentage of subjects
Interval 10.2 to 26.0

SECONDARY outcome

Timeframe: From date of randomization until date of death from any cause, assessed up to cut-off date (04-Jul-2015)

Population: ITT analysis set included all subjects who were randomized to trial treatment.

OS was defined as the time (in months) from randomization to death due to any cause. Subjects without a death date were to be censored at the minimum of last known date alive, defined as the latest date available on the electronic case report form, and cut-off date.

Outcome measures

Outcome measures
Measure
Dacarbazine
n=64 Participants
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
n=130 Participants
Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
Overall Survival (OS)
10.61 months
Interval 7.26 to 16.49
8.87 months
Interval 7.46 to 15.51

SECONDARY outcome

Timeframe: 12 months

Population: ITT analysis set included all subjects who were randomized to trial treatment.

OS was defined as the time (in months) from randomization to death due to any cause. Subjects without a death date were to be censored at the minimum of last known date alive, defined as the latest date available on the electronic case report form, and cut-off date. Percentage of Subjects with OS at 12 months were reported.

Outcome measures

Outcome measures
Measure
Dacarbazine
n=64 Participants
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
n=130 Participants
Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
Percentage of Subjects With Overall Survival (OS) at 12 Months
44.5 percentage of subjects
Interval 31.6 to 56.6
43.3 percentage of subjects
Interval 34.5 to 51.8

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 35, 36, 37 and EOT (up to cut-off date [04-Jul-2015])

Population: ITT analysis set. Here "Number of Subjects Analyzed" = subjects evaluable for this outcome and "Number Analyzed" = subjects evaluable at specified time points for each arm, respectively. There were no subjects analyzed at certain time points (that is, Number Analyzed = 0) because there was no data collected for respective arms at those time points.

QoL assessed using Function Assessment Cancer Therapy-melanoma (FACT-M) assessment tool. This includes 27-item FACT-General (FACT-G) questionnaire which consists of 24 questions;7 relating to physical well-being (PWB),7 relating to social/family well-being (SWB),6 relating to emotional well-being (EWB) and 7 relating to functional well-being (FWB). Also, it includes melanoma-specific subscale consists of 16 questions for Melanoma Subscale (MS) and 8 questions for Melanoma Surgery Scale (MSS).Each of these questions could have a response of Not at all, a little bit, somewhat, quite a bit and very much. The responses were given a value between 0 and 4 with 4 being best response. The FACT-M Total Score (FACT-M TS) ranges from 0 to 172 and is derived as follows: FACT-M TS= PWB Score + SWB Score + EWB Score + FWB Score + MS Score. Higher scores represent a better quality of life.

Outcome measures

Outcome measures
Measure
Dacarbazine
n=58 Participants
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
n=126 Participants
Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Baseline
126.20 units on a scale
Standard Deviation 23.828
132.24 units on a scale
Standard Deviation 22.179
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 2
-3.05 units on a scale
Standard Deviation 14.815
-3.06 units on a scale
Standard Deviation 18.492
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 3
0.60 units on a scale
Standard Deviation 19.965
-6.77 units on a scale
Standard Deviation 21.716
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 4
4.11 units on a scale
Standard Deviation 14.746
-6.54 units on a scale
Standard Deviation 19.919
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 5
0.62 units on a scale
Standard Deviation 11.810
-2.81 units on a scale
Standard Deviation 17.202
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 6
-3.71 units on a scale
Standard Deviation 15.674
-8.45 units on a scale
Standard Deviation 20.939
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 7
-1.10 units on a scale
Standard Deviation 13.318
-8.84 units on a scale
Standard Deviation 19.128
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 8
1.28 units on a scale
Standard Deviation 12.928
-14.67 units on a scale
Standard Deviation 18.508
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 9
2.21 units on a scale
Standard Deviation 16.224
-13.67 units on a scale
Standard Deviation 21.388
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 10
4.40 units on a scale
Standard Deviation 14.818
-13.26 units on a scale
Standard Deviation 20.716
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 11
1.02 units on a scale
Standard Deviation 19.161
-14.10 units on a scale
Standard Deviation 21.157
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 12
1.56 units on a scale
Standard Deviation 19.932
-10.52 units on a scale
Standard Deviation 18.895
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 13
5.51 units on a scale
Standard Deviation 20.191
-13.38 units on a scale
Standard Deviation 23.690
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 14
11.50 units on a scale
Standard Deviation 21.920
-18.24 units on a scale
Standard Deviation 22.998
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 15
9.60 units on a scale
Standard Deviation 15.345
-11.33 units on a scale
Standard Deviation 19.787
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 16
10.56 units on a scale
Standard Deviation 14.935
-11.18 units on a scale
Standard Deviation 23.680
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 17
3.00 units on a scale
Standard Deviation 5.657
-9.18 units on a scale
Standard Deviation 24.166
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 18
27.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
-3.92 units on a scale
Standard Deviation 9.640
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 19
16.50 units on a scale
Standard Deviation 14.849
-1.15 units on a scale
Standard Deviation 8.147
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 20
16.00 units on a scale
Standard Deviation 15.556
1.17 units on a scale
Standard Deviation 5.947
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 21
17.00 units on a scale
Standard Deviation 14.142
4.17 units on a scale
Standard Deviation 8.918
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 22
18.00 units on a scale
Standard Deviation 12.728
1.32 units on a scale
Standard Deviation 11.163
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 23
27.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
-13.69 units on a scale
Standard Deviation 15.354
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 24
13.50 units on a scale
Standard Deviation 19.092
-3.83 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 25
14.50 units on a scale
Standard Deviation 17.678
-3.83 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 26
27.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
-2.83 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 27
27.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 28
27.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
-0.83 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 30
-1.83 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 31
-7.83 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 32
-7.83 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 33
-8.83 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 35
-1.83 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 36
-3.83 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 37
-4.83 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at EOT
-7.91 units on a scale
Standard Deviation 23.119
-9.98 units on a scale
Standard Deviation 20.560

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 35, 36, 37 and EOT (up to cut-off date [04-Jul-2015])

Population: ITT analysis set. Here "Number of Subjects Analyzed" = subjects evaluable for this outcome and "Number Analyzed" = subjects evaluable at specified time points for each arm, respectively. There were no subjects analyzed at certain time points (that is, Number Analyzed = 0) because there was no data collected for respective arms at those time points.

QoL assessed using FACT-M assessment tool. This includes 27-item FACT-G questionnaire which consists of 24 questions; 7 relating to PWB, 7 relating to SWB, 6 relating to EWB and 7 relating to FWB. Also, it includes melanoma-specific subscale consists of 16 questions for MS and 8 questions for the MSS. Each of these questions could have a response of Not at all, a little bit, somewhat, quite a bit and very much. The responses were given a value between 0 and 4 with 4 being best response. The FACT-M Trial Outcome Index (FACT-M TOI) ranges from 0 to a high of 120 and is derived as: FACT-M TOI = PWB Score + FWB Score +MS Score. Higher scores represent a better quality of life.

Outcome measures

Outcome measures
Measure
Dacarbazine
n=58 Participants
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
n=126 Participants
Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Baseline
90.35 units on a scale
Standard Deviation 19.348
94.07 units on a scale
Standard Deviation 17.534
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 2
-3.33 units on a scale
Standard Deviation 12.015
-4.40 units on a scale
Standard Deviation 14.286
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 3
-0.69 units on a scale
Standard Deviation 15.974
-7.99 units on a scale
Standard Deviation 17.089
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 4
1.54 units on a scale
Standard Deviation 10.304
-7.97 units on a scale
Standard Deviation 16.741
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 5
-0.86 units on a scale
Standard Deviation 5.405
-4.37 units on a scale
Standard Deviation 14.084
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 6
-3.29 units on a scale
Standard Deviation 7.752
-9.15 units on a scale
Standard Deviation 18.813
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 7
-2.07 units on a scale
Standard Deviation 6.859
-8.99 units on a scale
Standard Deviation 14.783
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 8
0.83 units on a scale
Standard Deviation 5.161
-15.09 units on a scale
Standard Deviation 14.458
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 9
-1.93 units on a scale
Standard Deviation 6.300
-13.79 units on a scale
Standard Deviation 17.198
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 10
-1.10 units on a scale
Standard Deviation 5.654
-12.37 units on a scale
Standard Deviation 17.058
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 11
-2.90 units on a scale
Standard Deviation 7.722
-13.95 units on a scale
Standard Deviation 17.006
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 12
-2.40 units on a scale
Standard Deviation 7.408
-11.95 units on a scale
Standard Deviation 17.311
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 13
0.80 units on a scale
Standard Deviation 7.697
-13.57 units on a scale
Standard Deviation 21.699
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 14
0.00 units on a scale
Standard Deviation 4.243
-18.55 units on a scale
Standard Deviation 19.880
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 15
1.60 units on a scale
Standard Deviation 4.084
-13.59 units on a scale
Standard Deviation 15.747
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 16
0.61 units on a scale
Standard Deviation 3.994
-13.15 units on a scale
Standard Deviation 19.130
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 17
2.50 units on a scale
Standard Deviation 0.707
-10.66 units on a scale
Standard Deviation 20.007
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 18
3.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
-5.72 units on a scale
Standard Deviation 4.614
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 19
2.50 units on a scale
Standard Deviation 0.707
-4.94 units on a scale
Standard Deviation 5.238
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 20
4.00 units on a scale
Standard Deviation 1.414
-2.33 units on a scale
Standard Deviation 1.155
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 21
3.50 units on a scale
Standard Deviation 0.707
0.00 units on a scale
Standard Deviation 2.000
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 22
4.00 units on a scale
Standard Deviation 1.414
-1.40 units on a scale
Standard Deviation 3.831
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 23
3.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
-13.36 units on a scale
Standard Deviation 16.061
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 24
2.50 units on a scale
Standard Deviation 0.707
-2.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 25
3.50 units on a scale
Standard Deviation 0.707
-1.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 26
3.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
0.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 27
3.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 28
3.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
1.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 30
1.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 31
-3.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 32
-4.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 33
-3.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 35
0.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 36
0.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at Day 1 Cycle 37
-3.00 units on a scale
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed at the specified time point.
Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)
Change at EOT
-8.18 units on a scale
Standard Deviation 16.410
-10.42 units on a scale
Standard Deviation 16.256

SECONDARY outcome

Timeframe: Baseline up to cut-off date (04-Jul-2015)

Population: Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment.

AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 33 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs. TEAEs were to be reported separately for dacarbazine, pimasertib and pimasertib (crossover) reporting arms.

Outcome measures

Outcome measures
Measure
Dacarbazine
n=61 Participants
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
n=130 Participants
Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
n=41 Participants
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death
TEAEs
60 subjects
130 subjects
41 subjects
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death
Serious TEAEs
12 subjects
74 subjects
26 subjects
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death
TEAEs Leading to Discontinuation
3 subjects
61 subjects
16 subjects
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death
TEAEs Leading To Death
4 subjects
6 subjects
6 subjects

SECONDARY outcome

Timeframe: Baseline up to cut-off date (04-Jul-2015)

Population: Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment.

Adverse events of special interest included ocular retinal vein occlusion, serious retinal detachment or similar retinal abnormality characterized by accumulation of serous fluid in the retina, creatine phosphokinase (CPK) elevation and isoenzyme TEAE of Special Interest (Grade \>=2) and acute renal failure (Grade \>=2). Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.

Outcome measures

Outcome measures
Measure
Dacarbazine
n=61 Participants
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
n=130 Participants
Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
n=41 Participants
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
Number of Subjects With Adverse Events (AEs) of Special Interest
Retinal vein occlusion
0 subjects
5 subjects
2 subjects
Number of Subjects With Adverse Events (AEs) of Special Interest
Serious retinal detachment
0 subjects
76 subjects
21 subjects
Number of Subjects With Adverse Events (AEs) of Special Interest
CPK/Isoenzyme TEAE of Special Interest (>=Grade 2)
0 subjects
74 subjects
24 subjects
Number of Subjects With Adverse Events (AEs) of Special Interest
Acute renal failure (Grade >= 2)
1 subjects
9 subjects
2 subjects

SECONDARY outcome

Timeframe: Baseline up to cut-off date (04-Jul-2015)

Population: Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment.

Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.

Outcome measures

Outcome measures
Measure
Dacarbazine
n=61 Participants
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
n=130 Participants
Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
n=41 Participants
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
Number of Subjects With Clinically Significant Change From Baseline in Laboratory Parameter, Vital Signs, Electrocardiogram (ECG) and Ophthalmologic Findings
Laboratory Parameter
0 subjects
0 subjects
0 subjects
Number of Subjects With Clinically Significant Change From Baseline in Laboratory Parameter, Vital Signs, Electrocardiogram (ECG) and Ophthalmologic Findings
Vital Signs
0 subjects
0 subjects
0 subjects
Number of Subjects With Clinically Significant Change From Baseline in Laboratory Parameter, Vital Signs, Electrocardiogram (ECG) and Ophthalmologic Findings
ECG
0 subjects
0 subjects
0 subjects
Number of Subjects With Clinically Significant Change From Baseline in Laboratory Parameter, Vital Signs, Electrocardiogram (ECG) and Ophthalmologic Findings
Ophthalmologic Findings
0 subjects
0 subjects
0 subjects

Adverse Events

Dacarbazine

Serious events: 12 serious events
Other events: 59 other events
Deaths: 0 deaths

Pimasertib

Serious events: 74 serious events
Other events: 130 other events
Deaths: 0 deaths

Pimasertib (Crossover)

Serious events: 26 serious events
Other events: 41 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Dacarbazine
n=61 participants at risk
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
n=130 participants at risk
Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
n=41 participants at risk
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Anaemia
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Thrombocytopenia
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Acute coronary syndrome
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Acute myocardial infarction
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Atrial fibrillation
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Cardiac failure
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Cor pulmonale acute
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Left ventricular dysfunction
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Myocardial ischaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Pericarditis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Chorioretinopathy
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Cystoid macular oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Macular detachment
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Macular oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Retinal detachment
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Retinal vein occlusion
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Ulcerative keratitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Abdominal pain
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Constipation
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Diarrhoea
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.6%
6/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Duodenal obstruction
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Mouth ulceration
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Nausea
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Vomiting
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Chest pain
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Chills
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Cyst rupture
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Death
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Disease progression
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Fatigue
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
General physical health deterioration
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
9.8%
4/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Impaired healing
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Malaise
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Necrosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Lower respiratory tract infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Oedema peripheral
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Pyrexia
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Sudden death
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Hepatobiliary disorders
Cholangitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Hepatobiliary disorders
Hepatotoxicity
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Bacteraemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Candida infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Catheter site infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Cellulitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Device related infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Erysipelas
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
5.4%
7/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Localised infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Pharyngitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Pyelonephritis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Respiratory tract infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Sepsis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Septic shock
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Skin infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Staphylococcal sepsis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Streptococcal sepsis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Urinary tract infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Subdural haematoma
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Alanine aminotransferase increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Blood creatine phosphokinase increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
20.0%
26/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
19.5%
8/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Blood creatinine increased
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Ejection fraction decreased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Lipase increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Troponin increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Tumour lysis syndrome
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Inguinal mass
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Pathological fracture
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Spinal column stenosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Ataxia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Epilepsy
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Headache
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Metabolic encephalopathy
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Neuralgia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Neuropathy peripheral
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Presyncope
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Transient ischaemic attack
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Confusional state
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Renal and urinary disorders
Urinary retention
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Reproductive system and breast disorders
Breast haematoma
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Respiratory distress
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Drug eruption
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Rash macular
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Skin toxicity
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Deep vein thrombosis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Hypertension
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Hypotension
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Venous thrombosis limb
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.

Other adverse events

Other adverse events
Measure
Dacarbazine
n=61 participants at risk
Subjects received dacarbazine intravenously at dose of 1000 mg/m\^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib
n=130 participants at risk
Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover)
n=41 participants at risk
Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.
General disorders
Axillary pain
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Catheter site pain
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Chest discomfort
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Chest pain
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Crying
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Disease progression
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Drug intolerance
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Paraesthesia
14.8%
9/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Enanthema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Anaemia
13.1%
8/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
10.0%
13/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Thrombocytopenia
19.7%
12/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.2%
8/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Neutropenia
21.3%
13/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Lymphopenia
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.9%
9/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Leukopenia
9.8%
6/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Retinal detachment
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
43.1%
56/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
36.6%
15/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Vision blurred
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
22.3%
29/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
22.0%
9/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Eyelid oedema
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
13.8%
18/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Visual impairment
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
9.2%
12/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Periorbital oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
9.2%
12/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Macular detachment
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.7%
10/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Diarrhoea
16.4%
10/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
81.5%
106/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
75.6%
31/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Nausea
41.0%
25/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
36.2%
47/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
41.5%
17/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Vomiting
23.0%
14/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
23.1%
30/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
39.0%
16/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Constipation
34.4%
21/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
18.5%
24/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
17.1%
7/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Abdominal pain
16.4%
10/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
23.8%
31/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
17.1%
7/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Dry mouth
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
15.4%
20/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
19.5%
8/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Stomatitis
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
16.2%
21/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
9.8%
4/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Dyspepsia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
8.5%
11/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Gastrooesophageal reflux disease
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.2%
8/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Mouth ulceration
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
5.4%
7/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Oedema peripheral
9.8%
6/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
45.4%
59/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
43.9%
18/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Fatigue
37.7%
23/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
30.0%
39/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
26.8%
11/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Asthenia
21.3%
13/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
30.0%
39/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
24.4%
10/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Pyrexia
8.2%
5/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
20.8%
27/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
24.4%
10/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Chills
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
8.5%
11/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Blood creatine phosphokinase increased
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
66.2%
86/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
68.3%
28/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Aspartate aminotransferase increased
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
13.1%
17/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
9.8%
4/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Ejection fraction decreased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
10.0%
13/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Weight decreased
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.2%
8/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Alanine aminotransferase increased
6.6%
4/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.6%
6/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Weight increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.9%
9/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Blood alkaline phosphatase increased
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Gamma-glutamyltransferase increased
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Decreased appetite
13.1%
8/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
16.9%
22/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
17.1%
7/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hypokalaemia
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
10.0%
13/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
12.2%
5/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.7%
10/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
5.4%
7/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Myalgia
6.6%
4/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
13.8%
18/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
9.8%
4/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Arthralgia
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.9%
9/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
17.1%
7/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Back pain
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.2%
8/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
19.5%
8/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Pain in extremity
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.9%
9/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
14.6%
6/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Muscular weakness
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.2%
8/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Groin pain
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
9.8%
4/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Dizziness
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
13.1%
17/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
12.2%
5/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Headache
13.1%
8/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
12.3%
16/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Dysgeusia
9.8%
6/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
8.5%
11/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
9.8%
4/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Sciatica
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Dysaesthesia
6.6%
4/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Rash
8.2%
5/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
35.4%
46/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
43.9%
18/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
36.2%
47/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
22.0%
9/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Pruritus
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
13.1%
17/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
17.1%
7/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Erythema
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
10.8%
14/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
9.8%
4/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Skin fissures
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
13.1%
17/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Alopecia
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
10.0%
13/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
9.8%
4/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
9.2%
12/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
14.6%
6/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Dry skin
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
8.5%
11/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.2%
8/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Acne
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Anaemia of chronic disease
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Eosinophilia
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Hypochromic anaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Increased tendency to bruise
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Lymph node pain
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Lymphadenitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Lymphadenopathy
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Lymphocytosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Normochromic normocytic anaemia
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Blood and lymphatic system disorders
Thrombocytosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Angina pectoris
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Aortic valve disease
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Aortic valve incompetence
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Aortic valve stenosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Atrial fibrillation
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Atrioventricular block
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Atrioventricular block first degree
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Atrioventricular block second degree
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Bradycardia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Bundle branch block
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Bundle branch block right
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Diastolic dysfunction
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Left ventricular dysfunction
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Left ventricular hypertrophy
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Mitral valve incompetence
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Mitral valve sclerosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Palpitations
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Pericardial effusion
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Pulmonary valve incompetence
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Sinus bradycardia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Sinus tachycardia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Supraventricular tachycardia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Tachycardia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Tricuspid valve incompetence
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
9.8%
4/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Cardiac disorders
Ventricular hypokinesia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Congenital, familial and genetic disorders
Optic nerve hypoplasia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Congenital, familial and genetic disorders
Ventricular septal defect
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Ear and labyrinth disorders
Cerumen impaction
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Ear and labyrinth disorders
Ear congestion
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Ear and labyrinth disorders
Ear pain
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Ear and labyrinth disorders
Hypoacusis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Ear and labyrinth disorders
Middle ear inflammation
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Ear and labyrinth disorders
Tinnitus
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Ear and labyrinth disorders
Vertigo
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Endocrine disorders
Adrenal insufficiency
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Endocrine disorders
Hyperthyroidism
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Blepharitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Blindness
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Cataract
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Chalazion
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Chorioretinopathy
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Chromatopsia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Colour blindness acquired
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Conjunctival haemorrhage
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Conjunctival oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Cystoid macular oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Deposit eye
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Detachment of retinal pigment epithelium
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Diplopia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Dry eye
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Erythema of eyelid
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Eye discharge
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Eye disorder
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Eye haemorrhage
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Eye inflammation
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Eye oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Eye pain
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Eye pruritus
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Eye swelling
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Eyelid haematoma
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Eyelid ptosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Glaucoma
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Lacrimation increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Macular cyst
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Macular degeneration
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Macular fibrosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Macular oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.6%
6/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Myopia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Ocular hyperaemia
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Ocular hypertension
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Optic disc haemorrhage
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Photophobia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Photopsia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Presbyopia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Retinal deposits
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Retinal disorder
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Retinal haemorrhage
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Retinal oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Retinal pigment epitheliopathy
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Retinal vein occlusion
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Retinopathy
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Subretinal fluid
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Visual acuity reduced
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Vitreous detachment
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Vitreous floaters
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Eye disorders
Xerophthalmia
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Abdominal distension
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Dysphagia
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Anal polyp
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Aphthous stomatitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Aptyalism
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Ascites
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Cheilitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Colitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Epigastric discomfort
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Duodenal ulcer
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Faeces discoloured
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Flatulence
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Gastric ulcer
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Gastritis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Gastritis erosive
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Glossitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Glossodynia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Haematemesis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Haematochezia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Haemorrhoidal haemorrhage
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Haemorrhoids
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Hyperchlorhydria
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Lip dry
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Lip oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Lip pain
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Melaena
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Mesenteric vein thrombosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Mouth swelling
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Odynophagia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Oesophagitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Oral discomfort
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Oral dysaesthesia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Oral mucosal eruption
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Oral mucosal erythema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Oral pain
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Oral pruritus
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Oral toxicity
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Paraesthesia oral
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Tongue oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Regurgitation
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Salivary hypersecretion
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Hepatobiliary disorders
Hepatocellular injury
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
5.4%
7/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Hepatobiliary disorders
Hepatomegaly
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Subileus
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Tongue disorder
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Tongue ulceration
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Toothache
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Gastrointestinal disorders
Umbilical hernia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Pain
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Papillitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Peripheral swelling
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Secretion discharge
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Sensation of foreign body
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Temperature intolerance
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Vessel puncture site haematoma
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Vessel puncture site inflammation
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Vessel puncture site pain
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Xerosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Hepatobiliary disorders
Cholestasis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Hepatobiliary disorders
Hepatic pain
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Immune system disorders
Sarcoidosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Abdominal wall abscess
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Abscess limb
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Acute sinusitis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Acute tonsillitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Bacterial infection
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Bronchitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Cellulitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Cholangitis infective
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Conjunctivitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.2%
8/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Conjunctivitis viral
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Cystitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Enterobacter infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Erysipelas
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Folliculitis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
13.1%
17/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
17.1%
7/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Fungal oesophagitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Fungal skin infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Furuncle
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Gastroenteritis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Helicobacter infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Herpes simplex
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Herpes virus infection
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Herpes zoster
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Impetigo
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Infected bites
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Influenza
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Klebsiella infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Laryngitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Localised infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Lower respiratory tract infection
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Lung infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Lymph gland infection
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Nasopharyngitis
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.2%
8/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Oral candidiasis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Oral fungal infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Oral herpes
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Paronychia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.9%
9/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Pharyngitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Pneumonia escherichia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Pseudomonas infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Pulpitis dental
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Rash pustular
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
12.3%
16/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Rhinitis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Sinusitis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Skin candida
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Skin infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Staphylococcal bacteraemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Staphylococcal skin infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Superinfection viral
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Tinea cruris
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Tinea pedis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Tinea versicolour
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Tonsillitis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Tooth abscess
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Trichophytosis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Upper respiratory tract infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Urinary tract infection
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
5.4%
7/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Vaginal infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Viral infection
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Vulvovaginal mycotic infection
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Infections and infestations
Wound infection
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Chest injury
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Clavicle fracture
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Concussion
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Excoriation
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Fall
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Lip injury
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Muscle strain
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Optic nerve injury
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Procedural pain
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Rib fracture
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Scratch
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Spinal compression fracture
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Sunburn
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Tendon rupture
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Traumatic shock
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Wound
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Injury, poisoning and procedural complications
Wound complication
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Amylase increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Blood albumin decreased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Blood bicarbonate decreased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Blood bilirubin increased
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Blood creatinine increased
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Blood fibrinogen decreased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Blood lactate dehydrogenase increased
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Blood phosphorus increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Blood potassium increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Blood pressure increased
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Blood urea increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Body temperature increased
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Breath sounds abnormal
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
C-reactive protein increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Creatinine renal clearance decreased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Electrocardiogram PR prolongation
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Electrocardiogram QRS complex prolonged
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Electrocardiogram QT prolonged
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Electrocardiogram repolarisation abnormality
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Glomerular filtration rate decreased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Haemoglobin decreased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Hepatic enzyme increased
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
International normalised ratio increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Intraocular pressure increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Lipase increased
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Lymphocyte count decreased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Neutrophil count decreased
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Oxygen saturation decreased
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Platelet count decreased
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.6%
6/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Protein total decreased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Protein total increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Pupillary light reflex tests abnormal
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
Troponin increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
White blood cell count decreased
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Investigations
White blood cell count increased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Cell death
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Dehydration
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Diabetes mellitus
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Electrolyte imbalance
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Fluid retention
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Gout
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hyperamylasaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hyperglycaemia
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hyperlipasaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hyperphosphataemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hypertriglyceridaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hypophosphataemia
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Hypoproteinaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Increased appetite
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Iron deficiency
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Malnutrition
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Metabolism and nutrition disorders
Oligodipsia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Haemarthrosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Joint swelling
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Mobility decreased
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Muscle contracture
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Muscle spasms
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Muscle twitching
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Neck mass
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Neck pain
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Pain in jaw
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Spinal pain
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Tendonitis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Musculoskeletal and connective tissue disorders
Trismus
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blepharal papilloma
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Monoclonal gammopathy
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Autonomic nervous system imbalance
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Ageusia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Altered state of consciousness
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Amnesia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Aphasia
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Ataxia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Balance disorder
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Cervicobrachial syndrome
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Cognitive disorder
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Depressed level of consciousness
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Dizziness postural
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Dysarthria
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Hyperaesthesia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Hypoaesthesia
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Lethargy
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Loss of consciousness
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Memory impairment
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Migraine
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Motor dysfunction
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Muscle contractions involuntary
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Myasthenic syndrome
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Neuropathy peripheral
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Neurotoxicity
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Peripheral motor neuropathy
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Presyncope
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Sensorimotor disorder
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Sensory disturbance
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Somnolence
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.6%
6/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Syncope
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Tremor
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Nervous system disorders
Visual field defect
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Agitation
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Anxiety
9.8%
6/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Confusional state
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Depressed mood
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Depression
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Dyssomnia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Euphoric mood
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Hallucination
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Hallucination, visual
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Insomnia
6.6%
4/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
5.4%
7/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Irritability
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Mood altered
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Nervousness
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Nightmare
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Persecutory delusion
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Psychiatric disorders
Psychomotor retardation
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Renal and urinary disorders
Acute kidney injury
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Renal and urinary disorders
Cystitis noninfective
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Renal and urinary disorders
Dysuria
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.2%
8/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Renal and urinary disorders
Haematuria
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Renal and urinary disorders
Micturition urgency
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Renal and urinary disorders
Oliguria
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Renal and urinary disorders
Proteinuria
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Renal and urinary disorders
Renal injury
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Renal and urinary disorders
Renal vein occlusion
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Renal and urinary disorders
Urinary incontinence
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Renal and urinary disorders
Urinary retention
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Reproductive system and breast disorders
Amenorrhoea
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Reproductive system and breast disorders
Breast pain
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Reproductive system and breast disorders
Genital discomfort
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Reproductive system and breast disorders
Genital erythema
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Reproductive system and breast disorders
Haematospermia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Reproductive system and breast disorders
Pelvic pain
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Reproductive system and breast disorders
Scrotal haematocoele
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Reproductive system and breast disorders
Scrotal oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Atelectasis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Cough
8.2%
5/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.9%
9/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Dry throat
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Dysphonia
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
6.6%
4/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
20.0%
26/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
14.6%
6/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Epistaxis
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
6.2%
8/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Hypoventilation
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Lung disorder
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Nasal disorder
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Nasal oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Orthopnoea
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Petechiae
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Pharyngeal ulceration
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Rales
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Rhinalgia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Throat irritation
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Decubitus ulcer
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Diffuse alopecia
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Drug eruption
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Erythrosis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Hair growth abnormal
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Hirsutism
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Hyperhidrosis
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Hyperkeratosis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Ingrowing nail
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Intertrigo
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Nail bed inflammation
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Nail discolouration
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Nail disorder
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Night sweats
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Onycholysis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Pain of skin
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.6%
6/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Papule
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Photosensitivity reaction
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Pigmentation disorder
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Prurigo
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Pruritus generalised
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Rash erythematous
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Rash generalised
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Rash macular
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Rash morbilliform
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Rash papular
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Rash pruritic
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Rosacea
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Scab
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Skin burning sensation
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Skin erosion
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Skin exfoliation
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Skin irritation
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Skin lesion
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Skin mass
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Skin reaction
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Skin ulcer
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Solar dermatitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Stasis dermatitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Swelling face
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Toxic skin eruption
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Capillary leak syndrome
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Deep vein thrombosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Diastolic hypertension
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Flushing
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Haematoma
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Hot flush
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Hypertension
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
16.2%
21/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
14.6%
6/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Hypotension
4.9%
3/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.1%
4/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Lymphoedema
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
8.5%
11/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
7.3%
3/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Pelvic venous thrombosis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Peripheral coldness
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Peripheral ischaemia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Peripheral venous disease
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Phlebitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Thrombophlebitis
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Vascular compression
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Vena cava thrombosis
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
Vascular disorders
Venous thrombosis limb
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Face oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
9.2%
12/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
22.0%
9/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Facial pain
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Feeling cold
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Gait disturbance
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
General physical health deterioration
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Generalised oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Hyperpyrexia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Hyperthermia
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Hypothermia
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Inflammation
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Influenza like illness
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.3%
3/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Injection site haematoma
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Localised oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Malaise
3.3%
2/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
3.8%
5/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
4.9%
2/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Mucosal dryness
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.77%
1/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Non-cardiac chest pain
1.6%
1/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
0.00%
0/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
General disorders
Oedema
0.00%
0/61 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
1.5%
2/130 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.
2.4%
1/41 • Baseline up to cut-off date (04-Jul-2015)
Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.

Additional Information

Merck KGaA Communication Center

Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER