Trial Outcomes & Findings for Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC (MK0683-058) (NCT NCT00423449)
NCT ID: NCT00423449
Last Updated: 2016-02-04
Results Overview
DLT = any Common Terminology Criteria for Adverse Events Grade 3/4 drug related non-hematologic toxicity EXCEPT Grade 3 nausea/vomiting responsive to therapy, Grade 3 Fatigue responsive to management, transient electrolyte disorders that were corrected, any Grade 4 drug related hematologic toxicity EXCEPT lymphopenia/neutropenia, unless the neutropenia was febrile and/or was an infection requiring treatment, OR Any Grade 4 neutropenia lasting \>=7 days, failure of absolute neutrophil count or platelets to recover, or any drug-related AE that led to a dose reduction of \>=1 study drugs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
every 21 days (every cycle), up to 126 days (6 cycles)
Results posted on
2016-02-04
Participant Flow
Participant milestones
| Measure |
Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin
Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin
Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin
Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin
Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin
Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
17
|
27
|
7
|
|
Overall Study
COMPLETED
|
1
|
2
|
2
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
15
|
22
|
7
|
Reasons for withdrawal
| Measure |
Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin
Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin
Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin
Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin
Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin
Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
|---|---|---|---|---|---|
|
Overall Study
Clinical Adverse Event
|
1
|
0
|
1
|
8
|
2
|
|
Overall Study
Death
|
1
|
0
|
2
|
1
|
1
|
|
Overall Study
Progressive Disease
|
1
|
3
|
8
|
11
|
4
|
|
Overall Study
Laboratory Adverse Event
|
0
|
1
|
2
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
1
|
0
|
Baseline Characteristics
Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC (MK0683-058)
Baseline characteristics by cohort
| Measure |
All Participants
n=61 Participants
Vorinostat + Gemcitabine + Cisplatin
|
|---|---|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 21 days (every cycle), up to 126 days (6 cycles)DLT = any Common Terminology Criteria for Adverse Events Grade 3/4 drug related non-hematologic toxicity EXCEPT Grade 3 nausea/vomiting responsive to therapy, Grade 3 Fatigue responsive to management, transient electrolyte disorders that were corrected, any Grade 4 drug related hematologic toxicity EXCEPT lymphopenia/neutropenia, unless the neutropenia was febrile and/or was an infection requiring treatment, OR Any Grade 4 neutropenia lasting \>=7 days, failure of absolute neutrophil count or platelets to recover, or any drug-related AE that led to a dose reduction of \>=1 study drugs.
Outcome measures
| Measure |
Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin
n=4 Participants
Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin
n=6 Participants
Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin
n=17 Participants
Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin
n=27 Participants
Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin
n=7 Participants
Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: every 21 days (every cycle), up to 126 days (6 cycles)Maximum tolerated dose (MTD) was defined as the highest dose level in which fewer than 2 patients among the first 6 enrolled experience a DLT (as defined in Outcome Measure 1) during the first cycle of treatment. The MTD was 400 mg for up to 10 days in 21-day cycles.
Outcome measures
| Measure |
Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin
n=61 Participants
Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin
Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin
Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin
Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin
Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease
|
400 mg
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: every 21 days (every cycle), up to 126 days (6 cycles)An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience. The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively).
Outcome measures
| Measure |
Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin
n=4 Participants
Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin
n=6 Participants
Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin
n=17 Participants
Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin
n=27 Participants
Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin
n=7 Participants
Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinical Adverse Experiences (Safety and Tolerability)
|
4 Participants
|
6 Participants
|
17 Participants
|
27 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: every 21 days (every cycle), up to 126 days (6 cycles)An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience. The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively).
Outcome measures
| Measure |
Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin
n=4 Participants
Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin
n=6 Participants
Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin
n=17 Participants
Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin
n=27 Participants
Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin
n=7 Participants
Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m\^2 given on days 3 \& 10 of the 21 day cycle. Cisplatin 75 mg/m\^2 given on day 3 of th 21 day cycle.
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability)
|
2 Participants
|
4 Participants
|
7 Participants
|
13 Participants
|
2 Participants
|
Adverse Events
MK-0683 300 mg x 7d/21d + Gemcitabine 1000 mg/m^2 + Cisplatin
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-0683 300 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
MK-0683 400 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin
Serious events: 10 serious events
Other events: 17 other events
Deaths: 0 deaths
MK-0683 400 mg 10d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin
Serious events: 18 serious events
Other events: 27 other events
Deaths: 0 deaths
MK-0683 400 mg 14d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-0683 300 mg x 7d/21d + Gemcitabine 1000 mg/m^2 + Cisplatin
n=4 participants at risk
|
MK-0683 300 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin
n=6 participants at risk
|
MK-0683 400 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin
n=18 participants at risk
|
MK-0683 400 mg 10d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin
n=27 participants at risk
|
MK-0683 400 mg 14d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin
n=7 participants at risk
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
2/4 • Number of events 3
|
0.00%
0/6
|
0.00%
0/18
|
14.8%
4/27 • Number of events 5
|
28.6%
2/7 • Number of events 5
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Asthenia
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Chest pain
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
General disorders
Device occlusion
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Disease progression
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
11.1%
2/18 • Number of events 2
|
11.1%
3/27 • Number of events 3
|
0.00%
0/7
|
|
General disorders
General physical health deterioration
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
14.8%
4/27 • Number of events 4
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Hyperthermia
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
16.7%
3/18 • Number of events 3
|
0.00%
0/27
|
0.00%
0/7
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 2
|
0.00%
0/7
|
|
Infections and infestations
Lung infection
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Infections and infestations
Sepsis
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Septic shock
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Investigations
Blood potassium increased
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Liver function test abnormal
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Renal and urinary disorders
Bladder dilatation
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4
|
16.7%
1/6 • Number of events 2
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
5.6%
1/18 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
Other adverse events
| Measure |
MK-0683 300 mg x 7d/21d + Gemcitabine 1000 mg/m^2 + Cisplatin
n=4 participants at risk
|
MK-0683 300 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin
n=6 participants at risk
|
MK-0683 400 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin
n=18 participants at risk
|
MK-0683 400 mg 10d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin
n=27 participants at risk
|
MK-0683 400 mg 14d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin
n=7 participants at risk
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
4/4 • Number of events 11
|
100.0%
6/6 • Number of events 14
|
61.1%
11/18 • Number of events 33
|
85.2%
23/27 • Number of events 72
|
57.1%
4/7 • Number of events 27
|
|
Blood and lymphatic system disorders
Leukocytosis
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
1/4 • Number of events 4
|
33.3%
2/6 • Number of events 4
|
33.3%
6/18 • Number of events 22
|
33.3%
9/27 • Number of events 43
|
57.1%
4/7 • Number of events 21
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
2/4 • Number of events 2
|
33.3%
2/6 • Number of events 10
|
5.6%
1/18 • Number of events 1
|
29.6%
8/27 • Number of events 34
|
57.1%
4/7 • Number of events 13
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
2/4 • Number of events 7
|
66.7%
4/6 • Number of events 10
|
66.7%
12/18 • Number of events 51
|
55.6%
15/27 • Number of events 69
|
71.4%
5/7 • Number of events 20
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
75.0%
3/4 • Number of events 7
|
100.0%
6/6 • Number of events 15
|
55.6%
10/18 • Number of events 29
|
66.7%
18/27 • Number of events 55
|
71.4%
5/7 • Number of events 29
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
18.5%
5/27 • Number of events 15
|
0.00%
0/7
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
7.4%
2/27 • Number of events 2
|
0.00%
0/7
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
25.0%
1/4 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Ear and labyrinth disorders
Ototoxicity
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 2
|
0.00%
0/27
|
0.00%
0/7
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
11.1%
3/27 • Number of events 5
|
0.00%
0/7
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
7.4%
2/27 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
16.7%
3/18 • Number of events 3
|
7.4%
2/27 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4
|
16.7%
1/6 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
14.8%
4/27 • Number of events 4
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Aerophagia
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 4
|
33.3%
2/6 • Number of events 2
|
44.4%
8/18 • Number of events 12
|
33.3%
9/27 • Number of events 11
|
71.4%
5/7 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
22.2%
4/18 • Number of events 5
|
37.0%
10/27 • Number of events 11
|
42.9%
3/7 • Number of events 6
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
7.4%
2/27 • Number of events 2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
16.7%
3/18 • Number of events 3
|
7.4%
2/27 • Number of events 2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1
|
83.3%
5/6 • Number of events 12
|
61.1%
11/18 • Number of events 21
|
70.4%
19/27 • Number of events 43
|
57.1%
4/7 • Number of events 15
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
0.00%
0/18
|
7.4%
2/27 • Number of events 2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1
|
66.7%
4/6 • Number of events 6
|
38.9%
7/18 • Number of events 12
|
48.1%
13/27 • Number of events 33
|
71.4%
5/7 • Number of events 9
|
|
General disorders
Asthenia
|
100.0%
4/4 • Number of events 8
|
100.0%
6/6 • Number of events 10
|
66.7%
12/18 • Number of events 21
|
81.5%
22/27 • Number of events 39
|
71.4%
5/7 • Number of events 18
|
|
General disorders
Chest pain
|
25.0%
1/4 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
16.7%
3/18 • Number of events 4
|
14.8%
4/27 • Number of events 4
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Chills
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
7.4%
2/27 • Number of events 3
|
0.00%
0/7
|
|
General disorders
General physical health deterioration
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
General disorders
Generalised oedema
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
General disorders
Hyperthermia
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Influenza like illness
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
General disorders
Malaise
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Oedema peripheral
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
11.1%
3/27 • Number of events 4
|
0.00%
0/7
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
General disorders
Pyrexia
|
75.0%
3/4 • Number of events 4
|
33.3%
2/6 • Number of events 2
|
11.1%
2/18 • Number of events 2
|
22.2%
6/27 • Number of events 8
|
14.3%
1/7 • Number of events 1
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4
|
0.00%
0/6
|
11.1%
2/18 • Number of events 3
|
11.1%
3/27 • Number of events 3
|
0.00%
0/7
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Fungal infection
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Infections and infestations
Pseudomonal bacteraemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
7.4%
2/27 • Number of events 3
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/4
|
0.00%
0/6
|
11.1%
2/18 • Number of events 2
|
0.00%
0/27
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4
|
16.7%
1/6 • Number of events 6
|
5.6%
1/18 • Number of events 2
|
11.1%
3/27 • Number of events 6
|
28.6%
2/7 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1
|
16.7%
1/6 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
14.8%
4/27 • Number of events 9
|
42.9%
3/7 • Number of events 6
|
|
Investigations
Blood bicarbonate decreased
|
25.0%
1/4 • Number of events 1
|
33.3%
2/6 • Number of events 8
|
0.00%
0/18
|
7.4%
2/27 • Number of events 10
|
28.6%
2/7 • Number of events 4
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
0.00%
0/18
|
11.1%
3/27 • Number of events 5
|
0.00%
0/7
|
|
Investigations
Blood glucose increased
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
0.00%
0/7
|
|
Investigations
Blood lactate dehydrogenase increased
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/18
|
11.1%
3/27 • Number of events 4
|
0.00%
0/7
|
|
Investigations
Blood magnesium increased
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/18
|
7.4%
2/27 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood potassium increased
|
0.00%
0/4
|
16.7%
1/6 • Number of events 2
|
0.00%
0/18
|
7.4%
2/27 • Number of events 3
|
0.00%
0/7
|
|
Investigations
Blood sodium decreased
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
11.1%
3/27 • Number of events 4
|
0.00%
0/7
|
|
Investigations
Blood urea decreased
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/18
|
7.4%
2/27 • Number of events 2
|
0.00%
0/7
|
|
Investigations
Carbon dioxide decreased
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
7.4%
2/27 • Number of events 3
|
0.00%
0/7
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Investigations
Gamma-glutamyltransferase increased
|
25.0%
1/4 • Number of events 2
|
33.3%
2/6 • Number of events 7
|
16.7%
3/18 • Number of events 9
|
25.9%
7/27 • Number of events 27
|
42.9%
3/7 • Number of events 5
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 2
|
11.1%
3/27 • Number of events 3
|
14.3%
1/7 • Number of events 2
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
27.8%
5/18 • Number of events 13
|
22.2%
6/27 • Number of events 15
|
14.3%
1/7 • Number of events 6
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
27.8%
5/18 • Number of events 11
|
37.0%
10/27 • Number of events 20
|
28.6%
2/7 • Number of events 5
|
|
Investigations
Protein total decreased
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
11.1%
3/27 • Number of events 3
|
0.00%
0/7
|
|
Investigations
Protein urine present
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
7.4%
2/27 • Number of events 3
|
0.00%
0/7
|
|
Investigations
Weight decreased
|
0.00%
0/4
|
50.0%
3/6 • Number of events 3
|
0.00%
0/18
|
25.9%
7/27 • Number of events 8
|
28.6%
2/7 • Number of events 6
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 2
|
28.6%
2/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • Number of events 3
|
33.3%
2/6 • Number of events 3
|
44.4%
8/18 • Number of events 10
|
59.3%
16/27 • Number of events 22
|
71.4%
5/7 • Number of events 9
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hyperalbuminaemia
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/4
|
16.7%
1/6 • Number of events 5
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
1/4 • Number of events 5
|
33.3%
2/6 • Number of events 14
|
16.7%
3/18 • Number of events 9
|
33.3%
9/27 • Number of events 34
|
42.9%
3/7 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
1/4 • Number of events 1
|
16.7%
1/6 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
25.9%
7/27 • Number of events 22
|
42.9%
3/7 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
25.0%
1/4 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/18
|
25.9%
7/27 • Number of events 16
|
28.6%
2/7 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
3.7%
1/27 • Number of events 3
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
50.0%
2/4 • Number of events 2
|
33.3%
2/6 • Number of events 4
|
0.00%
0/18
|
22.2%
6/27 • Number of events 16
|
28.6%
2/7 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • Number of events 1
|
16.7%
1/6 • Number of events 6
|
0.00%
0/18
|
25.9%
7/27 • Number of events 20
|
28.6%
2/7 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4
|
16.7%
1/6 • Number of events 3
|
0.00%
0/18
|
18.5%
5/27 • Number of events 5
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
1/4 • Number of events 1
|
50.0%
3/6 • Number of events 4
|
5.6%
1/18 • Number of events 2
|
14.8%
4/27 • Number of events 10
|
42.9%
3/7 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Number of events 1
|
33.3%
2/6 • Number of events 9
|
11.1%
2/18 • Number of events 5
|
29.6%
8/27 • Number of events 16
|
42.9%
3/7 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
0.00%
0/27
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
16.7%
3/18 • Number of events 3
|
7.4%
2/27 • Number of events 2
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
11.1%
3/27 • Number of events 3
|
14.3%
1/7 • Number of events 2
|
|
Nervous system disorders
Formication
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Headache
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
16.7%
3/18 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
14.3%
1/7 • Number of events 3
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
14.8%
4/27 • Number of events 5
|
0.00%
0/7
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
22.2%
4/18 • Number of events 4
|
7.4%
2/27 • Number of events 2
|
28.6%
2/7 • Number of events 2
|
|
Psychiatric disorders
Confusional state
|
25.0%
1/4 • Number of events 3
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 2
|
0.00%
0/7
|
|
Psychiatric disorders
Depression
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
7.4%
2/27 • Number of events 2
|
0.00%
0/7
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4
|
0.00%
0/6
|
16.7%
3/18 • Number of events 3
|
14.8%
4/27 • Number of events 4
|
0.00%
0/7
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
7.4%
2/27 • Number of events 2
|
0.00%
0/7
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
7.4%
2/27 • Number of events 4
|
0.00%
0/7
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
7.4%
2/27 • Number of events 2
|
0.00%
0/7
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
16.7%
3/18 • Number of events 4
|
7.4%
2/27 • Number of events 2
|
28.6%
2/7 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
7.4%
2/27 • Number of events 2
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
22.2%
4/18 • Number of events 6
|
18.5%
5/27 • Number of events 5
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
18.5%
5/27 • Number of events 8
|
28.6%
2/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4
|
33.3%
2/6 • Number of events 3
|
33.3%
6/18 • Number of events 6
|
25.9%
7/27 • Number of events 13
|
42.9%
3/7 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
14.8%
4/27 • Number of events 6
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
0.00%
0/27
|
14.3%
1/7 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
0.00%
0/27
|
0.00%
0/7
|
|
Vascular disorders
Haematoma
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/18
|
7.4%
2/27 • Number of events 3
|
0.00%
0/7
|
|
Vascular disorders
Hypertension
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
0.00%
0/27
|
0.00%
0/7
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4
|
0.00%
0/6
|
5.6%
1/18 • Number of events 1
|
11.1%
3/27 • Number of events 3
|
0.00%
0/7
|
|
Vascular disorders
Thrombosis
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/18
|
3.7%
1/27 • Number of events 1
|
0.00%
0/7
|
Additional Information
Senior Vice President,Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER