Trial Outcomes & Findings for Trial of Gemcitabine With or Without MSC1936369B in Pancreatic Cancer (NCT NCT01016483)
NCT ID: NCT01016483
Last Updated: 2017-07-13
Results Overview
DLT using the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE) v3.0,was defined as any of the following toxicities at any dose level and judged to be possibly or probably related to trial medication by the Investigator and/or the Sponsor and relevant for the combination treatment: Grade 3/more non-hematological toxicity excluding: Subjects with liver involvement: Grade 4 asymptomatic increases in liver function tests and subject without liver involvement: Grade 3 asymptomatic increases in liver function tests reversible within 7 days. Grade 3 vomiting encountered despite adequate therapy. Grade 3 diarrhea encountered despite adequate anti diarrhea therapy. Grade 4 neutropenia greater (\>) 5 days duration or febrile neutropenia lasting for more than 1 day. Grade 4 thrombocytopenia \> 1 day/Grade 3 with bleeding. Grade 4 anemia: Any treatment delay \> 2 weeks due to drug-related adverse effects.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
141 participants
Primary outcome timeframe
Up to 28 days in Cycle 1
Results posted on
2017-07-13
Participant Flow
First/last subject (informed consent): Nov 2009/Jul 2013. Clinical data cut off: Dec 2013, Study completion date: April 2015
Participant milestones
| Measure |
Safety Run-in Part: Regimen 1
Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part: Regimen 2
Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks) (bid continuous regimen).
|
Phase II: Arm 1 (Gemcitabine + Placebo)
Subjects received gemcitabine 1000 mg/m\^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo matched to pimasertib orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
|
Phase II: Arm 2 (Gemcitabine + Pimasertib)
Subjects received gemcitabine 1000 mg/m\^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
|
|---|---|---|---|---|
|
Safety Run-in Part
STARTED
|
27
|
26
|
0
|
0
|
|
Safety Run-in Part
COMPLETED
|
27
|
26
|
0
|
0
|
|
Safety Run-in Part
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase II
STARTED
|
0
|
0
|
44
|
44
|
|
Phase II
Treated (Safety Analysis Set [SAF])
|
0
|
0
|
42
|
45
|
|
Phase II
COMPLETED
|
0
|
0
|
44
|
44
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Gemcitabine With or Without MSC1936369B in Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Safety Run-in Part: Regimen 1
n=27 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part: Regimen 2
n=26 Participants
Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Phase II: Arm 1 (Gemcitabine + Placebo)
n=44 Participants
Subjects received gemcitabine 1000 mg/m\^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo matched to pimasertib orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
|
Phase II: Arm 2 (Gemcitabine + Pimasertib)
n=44 Participants
Subjects received gemcitabine 1000 mg/m\^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=113 Participants
|
19 Participants
n=163 Participants
|
25 Participants
n=160 Participants
|
28 Participants
n=483 Participants
|
88 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=113 Participants
|
7 Participants
n=163 Participants
|
19 Participants
n=160 Participants
|
16 Participants
n=483 Participants
|
53 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=113 Participants
|
8 Participants
n=163 Participants
|
22 Participants
n=160 Participants
|
17 Participants
n=483 Participants
|
56 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=113 Participants
|
18 Participants
n=163 Participants
|
22 Participants
n=160 Participants
|
27 Participants
n=483 Participants
|
85 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days in Cycle 1Population: DLT analysis set included all subjects of safety run-in part who received any dose of pimasertib on at least 18 out of 20/25 out of 28 of the planned days on pimasertib \& least 3 gemcitabine weekly infusions during first 28 days of treatment or experienced DLT during the 28 first days of treatment regardless of the amount of each drug received.
DLT using the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE) v3.0,was defined as any of the following toxicities at any dose level and judged to be possibly or probably related to trial medication by the Investigator and/or the Sponsor and relevant for the combination treatment: Grade 3/more non-hematological toxicity excluding: Subjects with liver involvement: Grade 4 asymptomatic increases in liver function tests and subject without liver involvement: Grade 3 asymptomatic increases in liver function tests reversible within 7 days. Grade 3 vomiting encountered despite adequate therapy. Grade 3 diarrhea encountered despite adequate anti diarrhea therapy. Grade 4 neutropenia greater (\>) 5 days duration or febrile neutropenia lasting for more than 1 day. Grade 4 thrombocytopenia \> 1 day/Grade 3 with bleeding. Grade 4 anemia: Any treatment delay \> 2 weeks due to drug-related adverse effects.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=2 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
n=2 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
n=2 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
n=8 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
n=10 Participants
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
n=9 Participants
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Number of Subjects With Dose Limiting Toxicities (DLTs)
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
2 subjects
|
PRIMARY outcome
Timeframe: From the time of randomization to every 8 weeks up to end of treatment (EOT) (6 years)Population: Intent to Treat (ITT) analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).
PFS was defined as the time from randomization to the first documentation of objective tumor progression (Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline, Progressive Disease (PD): At least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started, or the appearance of 1 or more new lesions and stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started) or to death due to any cause, whichever occurred first. PFS calculated as (Months) = Date of first PD or death or censoring date minus date of randomization plus 1) divided by 30.4375.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=44 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=44 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Phase II: Progression-Free Survival (PFS) Time
|
2.83 months
Interval 1.77 to 3.88
|
3.75 months
Interval 2.63 to 5.09
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug administration until EOT (6 years)Population: Safety analysis set (SAF) for the safety run-in part included all subjects who had received at least 1 administration of the trial medication (pimasertib or gemcitabine).
An adverse event (AE) was any untoward medical occurrence in a subjects who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All AEs (serious and non-serious) except AEs recorded with an onset date prior to the first day of drug administration unless a worsening of the event was recorded after the first dosing date, in which case the event was counted as a TEAE. TEAEs include both SAEs and non-SAEs.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=27 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=26 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation
TEAEs
|
27 subjects
|
26 subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation
Serious TEAEs
|
18 subjects
|
20 subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation
Permanent treatment discontinuation of pimasertib
|
12 subjects
|
16 subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation
Permanent treatment discontinuation of gemcitabine
|
14 subjects
|
15 subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1Population: Pharmacokinetic set (PKS) of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day1. Here "n" signifies number of subjects evaluable for each category at specified time point.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=4 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
n=11 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) for Regimen 1
MSC1936369B on Days 1 (n=4,3,3,3,3,11)
|
32.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 107.5
|
131.0 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32.9
|
205.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30.0
|
151.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40.1
|
485.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 58.7
|
484.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39.8
|
—
|
—
|
|
Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) for Regimen 1
MSC1936369B on Days 22 (n= 3,3,3,2,3,10)
|
29.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39.8
|
174.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 29.6
|
261.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52.0
|
212.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 16.9
|
409.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 44.1
|
252.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 477.0
|
—
|
—
|
|
Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) for Regimen 1
Gemcitabine (dFdC) on Day 1 (n=4,3,3,3,3,11)
|
69540.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 1729.4
|
21207.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21.0
|
17759.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34.1
|
29762.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 76.7
|
15606.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 23.1
|
23880.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 83.8
|
—
|
—
|
|
Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) for Regimen 1
Gemcitabine (dFdC) on Day 22 (n= 2,3,3,2,3,9)
|
24115.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 71.9
|
11799.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 167.7
|
181.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39158542.7
|
163196.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 3183.3
|
669.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 3278825923
|
23207.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 99.5
|
—
|
—
|
|
Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) for Regimen 1
Metabolite (dFdU) on Day 1 (n= 4,3,3,3,3,11)
|
29359.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 8.5
|
33171.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21.2
|
34868.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 12.8
|
33804.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 16.7
|
37786.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 13.6
|
34038.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 29.7
|
—
|
—
|
|
Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) for Regimen 1
Metabolite (dFdU) on Day 22 (n= 2,3,3,2,3,10)
|
29677.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 3.0
|
38265.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 54.3
|
10569.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 449.2
|
32869.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 8.7
|
17135.0 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 227.5
|
21077.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 179.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1Population: PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here "n" signifies number of subjects evaluable for each category at specified time point.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=4 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
n=11 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
Tmax: MSC1936369B on Day 22 (n= 3,3,3 2,3,10)
|
2.017 hours
Interval 1.28 to 4.0
|
1.000 hours
Interval 0.5 to 2.5
|
1.000 hours
Interval 0.5 to 1.58
|
1.750 hours
Interval 1.0 to 2.5
|
1.500 hours
Interval 1.0 to 1.75
|
2.000 hours
Interval 0.83 to 8.0
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
Tmax: Gemcitabine (dFdC) on Day 22 (n=2,3,3,2,3,9)
|
0.42 hours
Interval 0.33 to 0.5
|
0.50 hours
Interval 0.5 to 1.58
|
0.53 hours
Interval 0.25 to 2.0
|
1.04 hours
Interval 1.0 to 1.08
|
0.25 hours
Interval 0.23 to 24.0
|
0.50 hours
Interval 0.25 to 0.75
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
Tmax: Metabolite (dFdU) on Day 22 (n=2,3,3,2,3,10
|
0.54 hours
Interval 0.33 to 0.75
|
0.75 hours
Interval 0.5 to 1.58
|
1.00 hours
Interval 0.73 to 2.0
|
0.67 hours
Interval 0.33 to 1.0
|
0.75 hours
Interval 0.5 to 24.0
|
0.75 hours
Interval 0.0 to 1.0
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
Tmax: MSC1936369B on Day 1 (n= 4,3,3,3,3,11)
|
1.250 hours
Interval 1.0 to 1.5
|
1.000 hours
Interval 1.0 to 2.5
|
1.533 hours
Interval 1.0 to 2.0
|
2.000 hours
Interval 0.67 to 8.0
|
1.083 hours
Interval 1.0 to 2.0
|
1.500 hours
Interval 0.5 to 4.0
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
Tmax: Gemcitabine (dFdC) on Day 1 (n=4,3,3,3,3,11)
|
0.38 hours
Interval 0.25 to 0.5
|
0.50 hours
Interval 0.25 to 0.5
|
0.25 hours
Interval 0.25 to 0.5
|
0.25 hours
Interval 0.25 to 1.17
|
0.25 hours
Interval 0.25 to 0.38
|
0.27 hours
Interval 0.25 to 0.75
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
Tmax: Metabolite (dFdU) on Day 1 (n=4,3,3,3,3,11)
|
0.64 hours
Interval 0.5 to 1.0
|
0.50 hours
Interval 0.5 to 0.75
|
0.50 hours
Interval 0.5 to 0.77
|
0.75 hours
Interval 0.67 to 1.0
|
0.50 hours
Interval 0.38 to 0.5
|
0.50 hours
Interval 0.25 to 0.75
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1Population: PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here "n" signifies number of subjects evaluable for each category at specified time point.
Plasma decay half-life was the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=4 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
n=11 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
t1/2: MSC1936369B on Day 1 (n=4,3,3,2,3,11)
|
4.008 hours
Interval 2.539 to 6.131
|
3.807 hours
Interval 3.373 to 6.648
|
3.833 hours
Interval 3.612 to 6.477
|
4.232 hours
Interval 3.382 to 5.083
|
5.036 hours
Interval 4.361 to 5.12
|
4.580 hours
Interval 3.394 to 6.938
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
t1/2: Gemcitabine (dFdC) on Day 1 (n=4,3,3,3,3,11)
|
4.274 hours
Interval 2.1 to 7.519
|
2.461 hours
Interval 1.239 to 6.821
|
2.421 hours
Interval 0.707 to 5.709
|
5.327 hours
Interval 5.148 to 5.338
|
8.940 hours
Interval 5.565 to 9.982
|
6.242 hours
Interval 0.8913 to 11.9
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
t1/2: Gemcitabine (dFdC) on Day 22 (n=2,2,1,2,2,9)
|
7.449 hours
Interval 6.032 to 8.866
|
4.553 hours
Interval 2.403 to 6.702
|
0.9152 hours
Interval 0.9152 to 0.9152
|
4.493 hours
Interval 2.721 to 6.266
|
8.213 hours
Interval 6.665 to 9.762
|
4.680 hours
Interval 0.8685 to 8.49
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
t1/2: MSC1936369B on Day 22 (n=2,2,3,2,3,8)
|
8.660 hours
Interval 4.709 to 12.61
|
6.100 hours
Interval 4.878 to 7.322
|
3.254 hours
Interval 3.048 to 6.999
|
5.744 hours
Interval 3.829 to 7.658
|
3.162 hours
Interval 2.903 to 6.341
|
4.825 hours
Interval 2.829 to 8.642
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
t1/2: Metabolite (dFdU) on Day 1 (n=4,3,3,3,3,11)
|
8.956 hours
Interval 8.129 to 14.68
|
10.49 hours
Interval 4.336 to 10.7
|
9.836 hours
Interval 9.383 to 14.69
|
11.52 hours
Interval 9.344 to 12.36
|
8.349 hours
Interval 7.191 to 9.551
|
10.93 hours
Interval 8.802 to 15.48
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
t1/2: Metabolite (dFdU) on Day 22(n=2,2,2,2,2,10)
|
7.731 hours
Interval 6.978 to 8.483
|
8.925 hours
Interval 8.299 to 9.552
|
8.843 hours
Interval 5.427 to 12.26
|
11.14 hours
Interval 9.119 to 13.17
|
10.21 hours
Interval 6.782 to 13.64
|
12.17 hours
Interval 3.468 to 211.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1 of Cycle 1 for MSC1936369B, 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1 for GemcitabinePopulation: PKS of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here "n" signifies number of subjects evaluable for each category at specified time point.
AUC:0 to infinity was a measure of the serum concentration of the drug over time. It was used to characterize drug absorption.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=4 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
n=11 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Area Under Curve (AUC: 0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
AUC: MSC1936369B on Day 1 (n=4,3,3,3,3,11)
|
162.8 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 25.3
|
516.3 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 32.9
|
881.1 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 37.1
|
774.8 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 58.9
|
1729.9 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 32.3
|
2175.1 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 53.0
|
—
|
—
|
|
Safety Run-In Part: Area Under Curve (AUC: 0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
AUC: Gemcitabine (dFdC) on Day 1(n=4,3,3,3,3,11)
|
29536.1 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 473.4
|
13536.5 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 40.4
|
10053.3 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 24.6
|
18956.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 37.2
|
8178.4 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 28.7
|
11680.1 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 59.0
|
—
|
—
|
|
Safety Run-In Part: Area Under Curve (AUC: 0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
AUC: Gemcitabine (dFdC) on Day 22(n=2,2,1,2,2,9)
|
10828.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 93.8
|
12019.6 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 29.5
|
9093.2 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
Data for Geometric Coefficient of Variation was not estimable as only one subject was analyzed.
|
76448.7 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 466.6
|
9604.8 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 11.9
|
10598.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 66.7
|
—
|
—
|
|
Safety Run-In Part: Area Under Curve (AUC: 0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
AUC: Metabolite (dFdU) on Day 1 (n=4,3,3,3,3,11)
|
245795.5 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 10.8
|
228032.9 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 27.6
|
276968.3 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 28.9
|
259816.2 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 9.2
|
239902.9 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 27.1
|
240293.8 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 15.0
|
—
|
—
|
|
Safety Run-In Part: Area Under Curve (AUC: 0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
AUC: Metabolite (dFdU) on Day 22 (n=2,2,2,2,2,10)
|
190952.6 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 9.3
|
376280.5 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 13.0
|
217930.8 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 70.4
|
327424.8 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 2.0
|
248496.4 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 5.2
|
247430.7 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 29.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1Population: PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here "n" signifies number of subjects evaluable for each category at specified time point.
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) was influenced by the fraction of the dose absorbed.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=4 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
n=11 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Apparent Oral Clearance (CL/f) of Pimasertib (MSC1936369B): Regimen 1
CL/f: MSC1936369B on Day 1 (n=4,3,3,2,3,11)
|
92.152 Liter per hour (L/h)
Geometric Coefficient of Variation 25.3
|
58.104 Liter per hour (L/h)
Geometric Coefficient of Variation 32.9
|
51.072 Liter per hour (L/h)
Geometric Coefficient of Variation 37.1
|
87.765 Liter per hour (L/h)
Geometric Coefficient of Variation 58.9
|
52.025 Liter per hour (L/h)
Geometric Coefficient of Variation 32.3
|
55.171 Liter per hour (L/h)
Geometric Coefficient of Variation 53.0
|
—
|
—
|
|
Safety Run-In Part: Apparent Oral Clearance (CL/f) of Pimasertib (MSC1936369B): Regimen 1
CL/f: MSC1936369B on Day 22 (n=2,2,3,2,3,9)
|
74.143 Liter per hour (L/h)
Geometric Coefficient of Variation 43.6
|
42.484 Liter per hour (L/h)
Geometric Coefficient of Variation 31.2
|
44.579 Liter per hour (L/h)
Geometric Coefficient of Variation 23.1
|
56.502 Liter per hour (L/h)
Geometric Coefficient of Variation 7.5
|
50.873 Liter per hour (L/h)
Geometric Coefficient of Variation 59.6
|
55.723 Liter per hour (L/h)
Geometric Coefficient of Variation 57.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1Population: PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here "n" signifies those subjects who were evaluable at the specified time point.
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=4 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
n=11 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Total Clearance (CL) of Gemcitabine: Regimen 1
CL: Gemcitabine on Day 1 (n=4,3,3,3,3,11)
|
60.537 liter/hour
Geometric Coefficient of Variation 483.4
|
133.88 liter/hour
Geometric Coefficient of Variation 45.1
|
190.52 liter/hour
Geometric Coefficient of Variation 26.0
|
95.96 liter/hour
Geometric Coefficient of Variation 47.7
|
210.25 liter/hour
Geometric Coefficient of Variation 27.9
|
151.93 liter/hour
Geometric Coefficient of Variation 54.7
|
—
|
—
|
|
Safety Run-In Part: Total Clearance (CL) of Gemcitabine: Regimen 1
CL: Gemcitabine on Day 22 (n=2,2,1,2,2,9)
|
163.37 liter/hour
Geometric Coefficient of Variation 93.7
|
156.93 liter/hour
Geometric Coefficient of Variation 20.1
|
190.69 liter/hour
Geometric Coefficient of Variation NA
Data for Geometric Coefficient of Variation was not estimable as only one subject was analyzed.
|
25.123 liter/hour
Geometric Coefficient of Variation 431.2
|
183.97 liter/hour
Geometric Coefficient of Variation 11.6
|
164.6 liter/hour
Geometric Coefficient of Variation 71.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1Population: PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here "n" signifies number of subjects evaluable for each category at specified time point.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=4 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
n=11 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Oral Volume of Distribution (V/f) of Pimasertib (MSC1936369B): Regimen 1
V/f: MSC1936369B on Day 1 (n=4,3,3,2,3,11)
|
528.62 liter
Geometric Coefficient of Variation 63.1
|
369.12 liter
Geometric Coefficient of Variation 5.0
|
329.80 liter
Geometric Coefficient of Variation 28.4
|
524.96 liter
Geometric Coefficient of Variation 26.2
|
362.29 liter
Geometric Coefficient of Variation 34.0
|
367.25 liter
Geometric Coefficient of Variation 50.5
|
—
|
—
|
|
Safety Run-In Part: Oral Volume of Distribution (V/f) of Pimasertib (MSC1936369B): Regimen 1
V/f: MSC1936369B on Day 22 (n=2,2,3,2,3,8)
|
824.33 liter
Geometric Coefficient of Variation 156.8
|
366.30 liter
Geometric Coefficient of Variation 1.8
|
264.31 liter
Geometric Coefficient of Variation 43.8
|
441.40 liter
Geometric Coefficient of Variation 43.4
|
284.42 liter
Geometric Coefficient of Variation 35.1
|
414.38 liter
Geometric Coefficient of Variation 66.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1Population: PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here "n" signifies number of subjects evaluable for each category at specified time point.
Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=4 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
n=11 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Apparent Volume of Distribution (V) of Gemcitabine: Regimen 1
V: Gemcitabine (dFdC) on Day 1 (n= 4,3,3,3,3,11)
|
359.55 liter
Geometric Coefficient of Variation 635.6
|
531.23 liter
Geometric Coefficient of Variation 64.7
|
587.64 liter
Geometric Coefficient of Variation 206.3
|
729.65 liter
Geometric Coefficient of Variation 46.3
|
2402.1 liter
Geometric Coefficient of Variation 59.5
|
1270.1 liter
Geometric Coefficient of Variation 82.0
|
—
|
—
|
|
Safety Run-In Part: Apparent Volume of Distribution (V) of Gemcitabine: Regimen 1
V: Gemcitabine (dFdC) on Day 22 (n=2,2,1,2,2,9)
|
1723.6 liter
Geometric Coefficient of Variation 55.9
|
908.50 liter
Geometric Coefficient of Variation 56.5
|
251.79 liter
Geometric Coefficient of Variation NA
Data for Geometric Coefficient of Variation was not estimable as only one subject was analyzed.
|
149.65 liter
Geometric Coefficient of Variation 1453.7
|
2140.8 liter
Geometric Coefficient of Variation 15.5
|
805.15 liter
Geometric Coefficient of Variation 138.0
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose on Day 1, 2, 22 of Cycle 1; post-dose on Day 1, 22 of Cycle 1Population: Pharmacodynamic population included SAF analysis set for the safety run-in part include all subjects who received at least 1 (non-zero) administration of the trial medication (pimasertib or gemcitabine). Here "n" signifies those subjects who were evaluable at the specified time point for each arm, respectively.
ERK phosphoprotein in peripheral blood monocytes (PBMCs) was analyzed from blood samples of all subjects in the SAF analysis set (safety-run part) only.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=2 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
n=2 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
n=3 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
n=7 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 1
Cycle 1 Day 22 Post-dose (n=0,0,0,0,2)
|
NA Fluorescence Intensity
Standard Deviation NA
No subjects were evaluable at the specified time point hence the parameter was not analyzed.
|
NA Fluorescence Intensity
Standard Deviation NA
No subjects were evaluable at the specified time point hence the parameter was not analyzed.
|
NA Fluorescence Intensity
Standard Deviation NA
No subjects were evaluable at the specified time point hence the parameter was not analyzed.
|
NA Fluorescence Intensity
Standard Deviation NA
No subjects were evaluable at the specified time point hence the parameter was not analyzed.
|
NA Fluorescence Intensity
Standard Deviation NA
No subjects were evaluable at the specified time point hence the parameter was not analyzed.
|
4.130 Fluorescence Intensity
Standard Deviation 1.772
|
—
|
—
|
|
Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 1
Cycle 1 Day 1 Pre-dose (n=3,2,2,3,3,7)
|
5.389 Fluorescence Intensity
Standard Deviation 0.797
|
6.476 Fluorescence Intensity
Standard Deviation 0.997
|
4.767 Fluorescence Intensity
Standard Deviation 0.114
|
6.509 Fluorescence Intensity
Standard Deviation 2.240
|
4.608 Fluorescence Intensity
Standard Deviation 0.197
|
4.229 Fluorescence Intensity
Standard Deviation 1.719
|
—
|
—
|
|
Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 1
Cycle 1 Day 1 Post-dose (n=3,2,2,3,2,6)
|
1.611 Fluorescence Intensity
Standard Deviation 0.537
|
2.061 Fluorescence Intensity
Standard Deviation 0.825
|
0.837 Fluorescence Intensity
Standard Deviation 0.149
|
3.881 Fluorescence Intensity
Standard Deviation 5.387
|
1.059 Fluorescence Intensity
Standard Deviation 0.042
|
0.946 Fluorescence Intensity
Standard Deviation 0.248
|
—
|
—
|
|
Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 1
Cycle 1 Day 2 Pre-dose (n=3,2,1,2,2,6)
|
4.818 Fluorescence Intensity
Standard Deviation 0.808
|
6.719 Fluorescence Intensity
Standard Deviation 2.835
|
3.902 Fluorescence Intensity
Standard Deviation NA
Data for standard deviation was not estimable as only one subject was analyzed.
|
2.768 Fluorescence Intensity
Standard Deviation 0.330
|
4.874 Fluorescence Intensity
Standard Deviation 2.119
|
3.636 Fluorescence Intensity
Standard Deviation 1.755
|
—
|
—
|
|
Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 1
Cycle 1 Day 22 Pre-dose (n=2,1,2,1,3,5)
|
5.242 Fluorescence Intensity
Standard Deviation 0.210
|
6.000 Fluorescence Intensity
Standard Deviation NA
Data for standard deviation was not estimable as only one subject was analyzed.
|
1.978 Fluorescence Intensity
Standard Deviation 2.539
|
8.653 Fluorescence Intensity
Standard Deviation NA
Data for standard deviation was not estimable as only one subject was analyzed.
|
4.252 Fluorescence Intensity
Standard Deviation 1.259
|
3.453 Fluorescence Intensity
Standard Deviation 0.860
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1Population: PKS of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here "n" signifies number of subjects evaluable for each category at specified time point.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=12 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=14 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
MSC1936369B on Day 1 (n= 12,13)
|
175.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 65.0
|
345.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
MSC1936369B on Day 22 (n=10,9)
|
228.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 59.0
|
244.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
Gemcitabine (dFdC) on Day 1 (n=11,14)
|
27849.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 344.0
|
17663.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 173.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
Gemcitabine (dFdC) on Day 22 (n=9,4)
|
21589.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 118.8
|
18733.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 88.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
Gemcitabine Metabolite (dFdU) on Day 1 (n=11, 10)
|
33033.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 11.8
|
31623.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
Gemcitabine Metabolite (dFdU) on Day 22 (n=10,5)
|
13455.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 546.0
|
18298.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 247.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1 of Cycle 1 for MSC1936369B, 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1 for GemcitabinePopulation: PKS of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here "n" signifies number of subjects evaluable for each category at specified time point.
AUC:0 to infinity is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=12 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=14 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Area Under Curve (AUC:0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) Regimen 2
AUC: MSC1936369B on Day 1 (n= 10, 11)
|
704.3 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 69.4
|
1427.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 30.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Area Under Curve (AUC:0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) Regimen 2
AUC: Gemcitabine (dFdC) on Day 1 (n= 11, 14)
|
11932.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 343.0
|
8065.5 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 176.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Area Under Curve (AUC:0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) Regimen 2
AUC: Gemcitabine (dFdC) on Day 22 (n= 9, 4)
|
10719.1 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 84.9
|
10102.3 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 72.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Area Under Curve (AUC:0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) Regimen 2
AUC: Metabolite (dFdU) on Day 1 (n= 11, 13)
|
189007.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 40.6
|
234934.8 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 29.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Area Under Curve (AUC:0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) Regimen 2
AUC: Metabolite (dFdU) on Day 22 (n= 10, 5)
|
177504.5 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 171.5
|
256714.9 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 37.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1Population: PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1.Here "n" signifies number of subjects evaluable for each category at specified time point.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=12 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=14 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
Tmax: MSC1936369B on Day 1 (n=12,13)
|
2.000 hours
Interval 0.5 to 3.98
|
1.583 hours
Interval 0.5 to 7.98
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
Tmax: MSC1936369B on Day 22 (n=10,9)
|
1.500 hours
Interval 0.25 to 4.4
|
2.000 hours
Interval 0.58 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
Tmax: Gemcitabine (dFdC) on Day 1 (n=11,14)
|
0.50 hours
Interval 0.25 to 0.73
|
0.38 hours
Interval 0.25 to 0.75
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
Tmax: Gemcitabine (dFdC) on Day 22 (n=9,4)
|
0.25 hours
Interval 0.0 to 0.5
|
0.25 hours
Interval 0.25 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
Tmax: Metabolite (dFdU) on Day 1 (n=11,13)
|
0.67 hours
Interval 0.5 to 0.75
|
0.67 hours
Interval 0.25 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
Tmax: Metabolite (dFdU) on Day 22 (n=10,5)
|
0.50 hours
Interval 0.0 to 2.0
|
0.50 hours
Interval 0.5 to 0.75
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1Population: PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here "n" signifies number of subjects evaluable for each category at specified time point.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=12 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=14 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
t1/2: MSC1936369B on Day 1 (n=10,11)
|
2.757 hours
Interval 2.183 to 3.557
|
2.603 hours
Interval 1.775 to 4.91
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
t1/2: MSC1936369B on Day 22 (n=8,5)
|
3.425 hours
Interval 2.584 to 10.6
|
3.188 hours
Interval 2.296 to 4.617
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
t1/2: Gemcitabine (dFdC) on Day 1 (n=11,14)
|
5.258 hours
Interval 0.796 to 8.757
|
5.376 hours
Interval 0.6681 to 11.64
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
t1/2: Gemcitabine (dFdC) on Day 22 (n=9,4)
|
5.522 hours
Interval 3.759 to 11.45
|
5.249 hours
Interval 0.3198 to 9.505
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
t1/2: Metabolite (dFdU) on Day 1 (n=11,13)
|
9.471 hours
Interval 6.559 to 13.1
|
10.26 hours
Interval 7.123 to 12.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
t1/2: Metabolite (dFdU) on Day 22 (n=10,5)
|
10.68 hours
Interval 6.543 to 441.9
|
13.58 hours
Interval 7.575 to 17.535
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1Population: PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here "n" signifies number of subjects evaluable for each category at specified time point.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=12 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=14 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Apparent Oral Clearance (CL/f) of Pimasertib (MSC1936369B): Regimen 2
CL/f: MSC1936369B on Day 1 (n=10,11)
|
85.186 Liter per hour (L/H)
Geometric Coefficient of Variation 69.4
|
52.558 Liter per hour (L/H)
Geometric Coefficient of Variation 30.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Apparent Oral Clearance (CL/f) of Pimasertib (MSC1936369B): Regimen 2
CL/f: MSC1936369B on Day 22 (n=8,5)
|
70.163 Liter per hour (L/H)
Geometric Coefficient of Variation 63.2
|
68.312 Liter per hour (L/H)
Geometric Coefficient of Variation 24.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1Population: PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here "n" signifies number of subjects evaluable for each category at specified time point.
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=12 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=14 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Total Clearance (CL) of Gemcitabine: Regimen 2
CL: Gemcitabine on Day 1 (n=11, 14)
|
145.65 liter/hour
Geometric Coefficient of Variation 363.2
|
221.46 liter/hour
Geometric Coefficient of Variation 186.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Total Clearance (CL) of Gemcitabine: Regimen 2
CL: Gemcitabine on Day 22 (n=9, 4)
|
164.68 liter/hour
Geometric Coefficient of Variation 81.4
|
183.85 liter/hour
Geometric Coefficient of Variation 73.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1Population: PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here "n" signifies number of subjects evaluable for each category at specified time point.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=12 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=14 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Apparent Volume of Distribution (V) of Gemcitabine: Regimen 2
V: Gemcitabine on Day 1 (n=11,14)
|
716.12 liter
Geometric Coefficient of Variation 343.3
|
1059.0 liter
Geometric Coefficient of Variation 196.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Apparent Volume of Distribution (V) of Gemcitabine: Regimen 2
V: Gemcitabine on Day 22 (n=9,4)
|
1590.8 liter
Geometric Coefficient of Variation 120.5
|
801.90 liter
Geometric Coefficient of Variation 130.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1Population: PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e. gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here "n" signifies number of subjects evaluable for each category at specified time point.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=12 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=14 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Oral Volume of Distribution (V/f) of Pimasertib (MSC1936369B): Regimen 2
V/f: MSC1936369B on Day 1 (n= 10,11)
|
335.56 liter
Geometric Coefficient of Variation 66.3
|
213.24 liter
Geometric Coefficient of Variation 37.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Oral Volume of Distribution (V/f) of Pimasertib (MSC1936369B): Regimen 2
V/f: MSC1936369B on Day 22 (n=8,5)
|
389.56 liter
Geometric Coefficient of Variation 47.1
|
319.02 liter
Geometric Coefficient of Variation 35.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose on Day 1, 2, 22 of Cycle 1; post-dose on Day 1, 22 of Cycle 1Population: Pharmacodynamic population included SAF analysis set for the safety run-in part include all subjects who received at least 1 (non-zero) administration of the trial medication (pimasertib or gemcitabine). Here "n" signifies those subjects who were evaluable at the specified time point for each arm respectively.
ERK phosphoprotein in peripheral blood monocytes (PBMCs) was analyzed from blood samples of all subjects in the SAF analysis set (safety-run part) only.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=7 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=4 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 2
Cycle 1 Day 1 Pre-dose (n=7,4)
|
6.081 Fluorescence Intensity
Standard Deviation 0.827
|
5.874 Fluorescence Intensity
Standard Deviation 2.239
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 2
Cycle 1 Day 1 Post-dose (n=5,3)
|
1.520 Fluorescence Intensity
Standard Deviation 0.109
|
1.048 Fluorescence Intensity
Standard Deviation 0.155
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 2
Cycle 1 Day 2 Pre-dose (n=7,3)
|
3.877 Fluorescence Intensity
Standard Deviation 2.099
|
2.263 Fluorescence Intensity
Standard Deviation 0.593
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 2
Cycle 1 Day 22 Pre-dose (n=6,2)
|
2.728 Fluorescence Intensity
Standard Deviation 0.818
|
2.295 Fluorescence Intensity
Standard Deviation 0.510
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 2
Cycle 1 Day 22 Post-dose (n=3,1)
|
1.443 Fluorescence Intensity
Standard Deviation 0.458
|
1.111 Fluorescence Intensity
Standard Deviation NA
Data for standard deviation was not estimable as only one subject was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug administration until EOT (6 years)Population: SAF for the Phase II included all subjects who had received at least 1 administration of the trial medication Gemcitabine or Placebo if the subject is in the gemcitabine + Placebo treatment arm (Arm 1) and MSC1936369B or gemcitabine in the MSC1936369B + gemcitabine treatment arm (Arm 2).
An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All AEs (serious and non-serious) except AEs recorded with an onset date prior to the first day of drug administration unless a worsening of the event was recorded after the first dosing date, in which case the event was counted as a TEAE. TEAEs include both SAEs and non-SAEs.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=42 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=45 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Phase II: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation
TEAEs
|
40 subjects
|
45 subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase II: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation
Serious TEAEs
|
28 subjects
|
35 subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase II: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation
TEAEs Leading to Treatment Discontinuation
|
10 subjects
|
21 subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks up to end of treatment (EOT i.e. 6 years)Population: ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).
Best overall response was defined as the presence of at least one complete response (CR), partial response (PR) or Stable Disease (SD) (using RECIST v1.0) during treatment. CR: Disappearance of all target lesions, PR: At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline and SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=44 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=44 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Phase II: Percentage of Subjects With Best Overall Response (BOR)
CR
|
0 percentage of subjects
|
0 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase II: Percentage of Subjects With Best Overall Response (BOR)
PR
|
9.1 percentage of subjects
|
9.1 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase II: Percentage of Subjects With Best Overall Response (BOR)
SD
|
36.4 percentage of subjects
|
50.0 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase II: Percentage of Subjects With Best Overall Response (BOR)
PD
|
29.5 percentage of subjects
|
20.5 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase II: Percentage of Subjects With Best Overall Response (BOR)
Missing
|
25 percentage of subjects
|
20.5 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks up to end of treatment (EOT i.e. 6 years)Population: ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).
Clinical Benefit was defined as the presence of at least one CR, PR or Stable Disease (SD) (using RECIST v1.0) during treatment. CR: Disappearance of all target lesions, PR: At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline and SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=44 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=44 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Phase II: Percentage of Subjects With Clinical Benefit
|
45.5 percentage of subjects
|
59.1 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization every 8 weeks up to EOT (6 years)Population: ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).
Time to progression (TTP) is defined as the time (in months) from the randomization date to the date of progression prior to the start of any subsequent therapy for the primary disease, as reported and documented by the Investigator (i.e. radiological progression per RECIST).
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=44 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=44 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Phase II: Time to Progression (TTP)
|
3.78 months
Interval 1.87 to 5.55
|
5.09 months
Interval 3.75 to 6.47
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks up to EOT (6 years)Population: ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).
Overall survival (OS) time is defined as the time (in months) from randomization to death.
Outcome measures
| Measure |
Safety Run-in Part Regimen 1: 15 mg
n=44 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 30 mg
n=44 Participants
Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 45 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 68 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 90 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 1: 120 mg
Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part Regimen 2: 60 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
Safety Run-in Part Regimen 2: 75 mg
Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
|
|---|---|---|---|---|---|---|---|---|
|
Phase II: Overall Survival (OS) Time
|
6.64 months
Interval 5.06 to
Upper limit of 95% Confidence Interval (CI) was not estimable due to limited number of events.
|
9.33 months
Interval 3.71 to
Upper limit of 95% Confidence Interval (CI) was not estimable due to limited number of events.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks up to EOT (6 years)Population: As per change in planned analysis, there was reduction of PK investigations for the phase II part of the trial, removal of PK sampling for gemcitabine and its metabolites and replacement of intense sampling with a sparse sampling scheme for pimasertib, thus the outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, every 8 weeks up to EOT (6 years)Population: As per change in planned analysis, there was reduction of PK investigations for the phase II part of the trial, removal of PK sampling for gemcitabine and its metabolites and replacement of intense sampling with a sparse sampling scheme for pimasertib, thus the outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, every 8 weeks up to EOT (6 years)Population: As per change in planned analysis, there was reduction of PK investigations for the phase II part of the trial, removal of PK sampling for gemcitabine and its metabolites and replacement of intense sampling with a sparse sampling scheme for pimasertib, thus the outcome measure was not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Safety Run-in Part: Regimen 1
Serious events: 18 serious events
Other events: 27 other events
Deaths: 0 deaths
Safety Run-in Part: Regimen 2
Serious events: 20 serious events
Other events: 26 other events
Deaths: 0 deaths
Phase II: Arm 1
Serious events: 28 serious events
Other events: 39 other events
Deaths: 0 deaths
Phase II: Arm 2
Serious events: 35 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Run-in Part: Regimen 1
n=27 participants at risk
Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part: Regimen 2
n=26 participants at risk
Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Phase II: Arm 1
n=42 participants at risk
Subjects received gemcitabine 1000 mg/m\^2 for 30 minutes IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib orally 60 mg bid - continuous regimen.
|
Phase II: Arm 2
n=45 participants at risk
Subjects received gemcitabine 1000 mg/m\^2 for 30 minutes IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib orally 60 mg bid - continuous regimen.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Leukaemoid reaction
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.1%
3/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Macular detachment
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Retinal Vein Occlusion
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Retinal detachment
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Ascites
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Mesenteric Vein Thrombosis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
9.5%
4/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Asthenia
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Chills
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Disease progression
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.9%
5/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Fatigue
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
General physical health deterioration
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Malaise
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Oedema Peripheral
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Pyrexia
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
23.1%
6/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.9%
5/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.1%
5/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Cholangitis
|
11.1%
3/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Cholangitis Acute
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.1%
3/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Jaundice extrahepatic obstructive
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Cystitis klebsiella
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Device related infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Furuncle
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Genital herpes
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Hepatitis c
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Liver abscess
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Lung Infection
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Pulmonary sepsis
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Respiratory tract infection
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Sepsis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Tonsillitis
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Viral infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.1%
3/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.1%
5/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
9.5%
4/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Blood potassium decreased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Lipase increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Platelet count decreased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Ataxia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Coma
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Headache
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Polyneuropathy
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Syncope
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Psychiatric disorders
Depression
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Psychiatric disorders
Disorientation
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
3/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Surgical and medical procedures
Palliative Care
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Vascular disorders
Capillary Leak Syndrome
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Vascular disorders
Hypertension
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Amylase increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
Other adverse events
| Measure |
Safety Run-in Part: Regimen 1
n=27 participants at risk
Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Safety Run-in Part: Regimen 2
n=26 participants at risk
Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
|
Phase II: Arm 1
n=42 participants at risk
Subjects received gemcitabine 1000 mg/m\^2 for 30 minutes IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib orally 60 mg bid - continuous regimen.
|
Phase II: Arm 2
n=45 participants at risk
Subjects received gemcitabine 1000 mg/m\^2 for 30 minutes IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib orally 60 mg bid - continuous regimen.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
51.9%
14/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
23.1%
6/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
40.5%
17/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
37.8%
17/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
63.0%
17/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
50.0%
13/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
21.4%
9/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
35.6%
16/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Anaemia
|
37.0%
10/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
34.6%
9/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
19.0%
8/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
28.9%
13/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Leukopenia
|
18.5%
5/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
15.4%
4/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
14.3%
6/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Retinal detachment
|
37.0%
10/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
53.8%
14/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
22.2%
10/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Macular degeneration
|
14.8%
4/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.5%
3/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Visual acuity reduced
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.5%
3/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Visual impairment
|
18.5%
5/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Eyelid oedema
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
15.4%
4/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Vision blurred
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Diarrhoea
|
51.9%
14/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
73.1%
19/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
19.0%
8/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
44.4%
20/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
9/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
15.4%
4/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
26.2%
11/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
15.6%
7/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
9/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
23.1%
6/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
19.0%
8/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
17.8%
8/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
16.7%
7/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Dry mouth
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Nausea
|
59.3%
16/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
57.7%
15/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
35.7%
15/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
51.1%
23/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Vomiting
|
48.1%
13/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
46.2%
12/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
26.2%
11/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
48.9%
22/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Stomatitis
|
44.4%
12/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
46.2%
12/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
9.5%
4/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
33.3%
15/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Fatigue
|
55.6%
15/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
19.2%
5/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
40.5%
17/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
37.8%
17/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Oedema peripheral
|
51.9%
14/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
57.7%
15/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
19.0%
8/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
48.9%
22/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Pyrexia
|
51.9%
14/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
42.3%
11/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
28.6%
12/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
37.8%
17/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Asthenia
|
29.6%
8/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
50.0%
13/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
14.3%
6/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
20.0%
9/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.5%
3/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
16.7%
7/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
20.0%
9/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Alanine aminotransferase increased
|
22.2%
6/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
15.4%
4/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
9.5%
4/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Aspartate aminotransferase increased
|
14.8%
4/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
19.2%
5/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.1%
3/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
14.3%
6/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Blood alkaline phosphatase increased
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.5%
3/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.1%
3/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Platelet count decreased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.1%
5/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Weight decreased
|
11.1%
3/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
9.5%
4/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Ejection fraction decreased
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.0%
10/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
42.3%
11/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
21.4%
9/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
31.1%
14/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
3/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
13.3%
6/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
23.1%
6/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.1%
3/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
19.2%
5/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
9.5%
4/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.5%
3/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.9%
5/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.1%
3/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.2%
6/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
26.9%
7/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.1%
3/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
13.3%
6/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.5%
5/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.5%
3/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.1%
3/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.8%
4/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
23.1%
6/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
9.5%
4/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
44.4%
20/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
15.4%
4/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
25.9%
7/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
15.4%
4/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.1%
5/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
22.2%
6/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
26.9%
7/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.1%
5/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
3/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Vascular disorders
Hypotension
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Normochromic Normocytic Anaemia
|
18.5%
5/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Anaemia of Chronic Disease
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Ascites
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Acne
|
33.3%
9/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
34.6%
9/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Exfoliative Rash
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Pain of Skin
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.5%
3/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.5%
3/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.5%
3/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
15.4%
4/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
15.4%
4/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Haemoglobin Decreased
|
11.1%
3/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Transaminases Increased
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Dysgeusia
|
22.2%
6/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
15.4%
4/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Headache
|
22.2%
6/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.5%
3/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
15.6%
7/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
18.5%
5/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.5%
5/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
15.4%
4/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
11.1%
3/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
3/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
19.2%
5/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Psychiatric disorders
Insomnia
|
11.1%
3/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Psychiatric disorders
Anxiety
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Vascular disorders
Hypertension
|
18.5%
5/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.5%
3/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Ear and labyrinth disorders
Vertigo
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
6.7%
3/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Haemoglobinaemia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Cardiac disorders
Dilatation ventricular
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Cardiac disorders
Palpitations
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Cardiac disorders
Pericardial effusion
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Scotoma
|
14.8%
4/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
19.2%
5/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Papilloedema
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Colour blindness acquired
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Conjunctival haemorrhage
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Eye haemorrhage
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Retinal pigment epitheliopathy
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Retinal vascular disorder
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Retinal vein occlusion
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
15.4%
4/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Macular oedema
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Eye swelling
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Ocular toxicity
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Photophobia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Retinal exudates
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Retinoschisis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Uveitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Macular detachment
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
15.6%
7/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Detachment of macular retinal pigment epithelium
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Arteriosclerotic retinopathy
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Eye disorder
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Eye inflammation
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Eye oedema
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Glaucoma
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Photopsia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Eye disorders
Retinal disorder
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Abdominal distension
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Enteritis
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Eructation
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Flatulence
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Oral submucosal fibrosis
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Palatal oedema
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Enlarged uvula
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Aerophagia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Influenza like illness
|
18.5%
5/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Oedema
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Chills
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.1%
3/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Face oedema
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Feeling cold
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Generalised oedema
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
11.5%
3/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
General physical health deterioration
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Hypothermia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Localised oedema
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Malaise
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Chest discomfort
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Device failure
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Disease progression
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Early satiety
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Feeling hot
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Inflammation
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Injection site haematoma
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
General disorders
Injection site reaction
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Jaundice
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.1%
3/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
8.9%
4/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
BRONCHITIS
|
11.1%
3/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Lung infection
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Paronychia
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Escherichia infection
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Gastroenteritis
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Influenza
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Oral fungal infection
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Oral herpes
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Pneumonia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Pneumonia klebsiella
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Tonsillitis
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Tooth infection
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Urinary tract infection
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.1%
3/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Pneumocystis jiroveci infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Rash pustular
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Cystitis klebsiella
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Device related infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Ear infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Fungal infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Furuncle
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Infections and infestations
Viral infection
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Injury, poisoning and procedural complications
Fall
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Injury, poisoning and procedural complications
Open wound
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
C-reactive protein increased
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Visual field tests abnormal
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Blood potassium increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Blood sodium increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Transferrin saturation decreased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Weight increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.1%
3/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Blood albumin increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Blood iron decreased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Blood creatine increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Blood glucose increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Body temperature increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Investigations
Vitamin D decreased
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Fluid retention
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Gout
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
7.4%
2/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Aphonia
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Presyncope
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Restless leg syndrome
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Allodynia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Amnesia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Syncope
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Psychiatric disorders
Depression
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Psychiatric disorders
Libido decreased
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Renal and urinary disorders
Haematuria
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Reproductive system and breast disorders
Epididymal tenderness
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Reproductive system and breast disorders
Prostatism
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
7.7%
2/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Pityriasis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Skin oedema
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.8%
2/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Vascular disorders
Deep vein thrombosis
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.2%
1/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Vascular disorders
Phlebitis
|
3.7%
1/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
2.4%
1/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Vascular disorders
Pallor
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
3.8%
1/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/27 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/26 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
0.00%
0/42 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
4.4%
2/45 • From the first dose of study drug administration until EOT (6 years)
Adverse Events were collected for SAF. SAF for safety run-in part included all subjects who had received at least 1 administration of trial medication (pimasertib or gemcitabine). SAF for Phase II included all subjects who had received at least 1 administration of trial medication Gemcitabine or Placebo if subject is in gemcitabine + Placebo arm (Arm 1) or at least 1 administration of trial medication MSC1936369B or gemcitabine if subject is in MSC1936369B + gemcitabine arm (Arm 2).
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a business of Merck KGaA, Darmstadt, Germany
Phone: +496151725200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER