Trial Outcomes & Findings for A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers (MK-0683-007) (NCT NCT00907738)
NCT ID: NCT00907738
Last Updated: 2015-05-21
Results Overview
A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose. A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)
Results posted on
2015-05-21
Participant Flow
Participant milestones
| Measure |
Base Protocol 001
Vorinostat 400 mg daily (QD)
|
Base Protocol 006
vorinostat 200 mg twice daily (BID)
|
Base Protocol 008
vorinostat 400 mg QD
|
Base Protocol 012
400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel \& cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
|
Base Protocol 013
vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
1
|
7
|
4
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
1
|
7
|
4
|
2
|
Reasons for withdrawal
| Measure |
Base Protocol 001
Vorinostat 400 mg daily (QD)
|
Base Protocol 006
vorinostat 200 mg twice daily (BID)
|
Base Protocol 008
vorinostat 400 mg QD
|
Base Protocol 012
400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel \& cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
|
Base Protocol 013
vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
not specified or withdrew consent
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Disease progression
|
8
|
1
|
6
|
4
|
2
|
Baseline Characteristics
A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers (MK-0683-007)
Baseline characteristics by cohort
| Measure |
Base Protocol 001
n=13 Participants
Vorinostat 400 mg daily (QD)
|
Base Protocol 006
n=1 Participants
vorinostat 200 mg twice daily (BID)
|
Base Protocol 008
n=7 Participants
vorinostat 400 mg QD
|
Base Protocol 012
n=4 Participants
400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel \& cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
|
Base Protocol 013
n=2 Participants
vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
|
13 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
27 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
15 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose. A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug.
Outcome measures
| Measure |
Base Protocol 001
n=13 Participants
Vorinostat 400 mg daily (QD)
|
Base Protocol 006
n=1 Participants
vorinostat 200 mg twice daily (BID)
|
Base Protocol 008
n=7 Participants
vorinostat 400 mg QD
|
Base Protocol 012
n=4 Participants
400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel \& cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
|
Base Protocol 013
n=2 Participants
vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
|
|---|---|---|---|---|---|
|
Percent of Participants With a Serious Drug-related Adverse Event (AE)
|
7.7 percent of participants
|
0 percent of participants
|
0 percent of participants
|
0 percent of participants
|
0 percent of participants
|
Adverse Events
Base Protocol 001 (Vorinostat 400 mg Once Daily [QD])
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID])
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Base Protocol 008 (Vorinostat 400 mg Once Daily [QD])
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Base Protocol 001 (Vorinostat 400 mg Once Daily [QD])
n=13 participants at risk
|
Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID])
n=1 participants at risk
|
Base Protocol 008 (Vorinostat 400 mg Once Daily [QD])
n=7 participants at risk
|
Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21)
n=1 participants at risk
|
Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7)
n=1 participants at risk
|
Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21)
n=1 participants at risk
|
Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21)
n=1 participants at risk
|
Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21)
n=1 participants at risk
|
Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)
n=1 participants at risk
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/13
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
100.0%
1/1 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/13
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
100.0%
1/1 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Hepatobiliary disorders
Cholecystitis
|
7.7%
1/13 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.7%
1/13 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/13
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
14.3%
1/7 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/13
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
14.3%
1/7 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
7.7%
1/13 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
Other adverse events
| Measure |
Base Protocol 001 (Vorinostat 400 mg Once Daily [QD])
n=13 participants at risk
|
Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID])
n=1 participants at risk
|
Base Protocol 008 (Vorinostat 400 mg Once Daily [QD])
n=7 participants at risk
|
Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21)
n=1 participants at risk
|
Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7)
n=1 participants at risk
|
Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21)
n=1 participants at risk
|
Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21)
n=1 participants at risk
|
Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21)
n=1 participants at risk
|
Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)
n=1 participants at risk
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
23.1%
3/13 • Number of events 4
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
100.0%
1/1 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/13
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
14.3%
1/7 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
2/13 • Number of events 2
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
100.0%
1/1 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
General disorders
Fatigue
|
0.00%
0/13
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
100.0%
1/1 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/13
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
100.0%
1/1 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.7%
1/13 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.7%
1/13 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/13
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
14.3%
1/7 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
1/13 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Renal and urinary disorders
Haematuria
|
7.7%
1/13 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.7%
1/13 • Number of events 1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/7
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
0.00%
0/1
The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1. Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.
|
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