Trial Outcomes & Findings for A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056) (NCT NCT00473889)

NCT ID: NCT00473889

Last Updated: 2015-07-03

Results Overview

Defined as the time from date of randomization to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 253 participants
• Primary outcome timeframe: Start of treatment to death
• Results posted on: 2015-07-03

Participant Flow

This study was conducted at 99 investigative sites worldwide. The first patient's first visit was 16 May 07 and the last patient's last visit was 12 Dec 2008.

Randomized participants were stratified by Stage (IIIB versus IV), geographic region and eligibility for treatment with bevacizumab prior to treatment assignment.

Participant milestones

Measure	Vorinostat + Paclitaxel + Carboplatin Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.	Placebo + Paclitaxel + Carboplatin Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
Overall Study STARTED	126	127
Overall Study COMPLETED	43	63
Overall Study NOT COMPLETED	83	64

Reasons for withdrawal

Measure	Vorinostat + Paclitaxel + Carboplatin Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.	Placebo + Paclitaxel + Carboplatin Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
Overall Study Did not receive study medication	1	4
Overall Study Adverse Event	30	17
Overall Study Protocol Violation	4	2
Overall Study Lack of Efficacy	28	29
Overall Study Lost to Follow-up	2	1
Overall Study Physician Decision	10	5
Overall Study Trial Terminated	3	6
Overall Study Withdrawal by Subject	5	0

Baseline Characteristics

A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056)

Baseline characteristics by cohort

Measure	Vorinostat + Paclitaxel + Carboplatin n=126 Participants Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.	Placebo + Paclitaxel + Carboplatin n=127 Participants Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.	Total n=253 Participants Total of all reporting groups
Age, Customized Less Than 65 years	70 participants n=5 Participants	89 participants n=7 Participants	159 participants n=5 Participants
Age, Customized 65 years or Older	56 participants n=5 Participants	38 participants n=7 Participants	94 participants n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	56 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	71 Participants n=7 Participants	163 Participants n=5 Participants
Race/Ethnicity, Customized White	79 participants n=5 Participants	79 participants n=7 Participants	158 participants n=5 Participants
Race/Ethnicity, Customized Black	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Race/Ethnicity, Customized Asian	31 participants n=5 Participants	32 participants n=7 Participants	63 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native mix	13 participants n=5 Participants	12 participants n=7 Participants	25 participants n=5 Participants
Cancer Stage IIIB	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Cancer Stage IV	112 Participants n=5 Participants	112 Participants n=7 Participants	224 Participants n=5 Participants
Eligibility to receive treatment with Bevacizumab Eligible	70 Participants n=5 Participants	63 Participants n=7 Participants	133 Participants n=5 Participants
Eligibility to receive treatment with Bevacizumab Ineligible	55 Participants n=5 Participants	60 Participants n=7 Participants	115 Participants n=5 Participants
Eligibility to receive treatment with Bevacizumab Unknown	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Geographic region where the participant lived North America	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Geographic region where the participant lived Europe (United Kingdom, Italy, Germany, and Spain)	41 Participants n=5 Participants	40 Participants n=7 Participants	81 Participants n=5 Participants
Geographic region where the participant lived Asia	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Geographic region where the participant lived Rest of the World	38 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants

PRIMARY outcome

Timeframe: Start of treatment to death

Population: Intention-to-treat (ITT) population is defined as all randomized participants. Participants are counted in the group to which they are randomized.

Defined as the time from date of randomization to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up.

Outcome measures

Measure	Vorinostat + Paclitaxel + Carboplatin n=126 Participants Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.	Placebo + Paclitaxel + Carboplatin n=127 Participants Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
Overall Survival	11.0 Months Interval 0.2 to 17.3	14.0 Months Interval 0.03 to 18.7

SECONDARY outcome

Timeframe: Start of treatment to disease progression or death

Population: Full analysis set (FAS) population defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study 5 didn't take any study medication. Therefore, 248 participants are included in this analysis population.

Defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in sum of the longest diameter of all target lesions, the appearance of a new lesion, or an increase in non-target lesions.

Outcome measures

Measure	Vorinostat + Paclitaxel + Carboplatin n=125 Participants Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.	Placebo + Paclitaxel + Carboplatin n=123 Participants Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
Progression Free Survival	4.3 Months Interval 0.03 to 13.4	5.5 Months Interval 0.03 to 13.8

SECONDARY outcome

Timeframe: Every 42 days from start of treatment until disease response

Population: Full analysis set (FAS) population is defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study. Five (5) didn't take any study medication. Therefore, 248 participants are included in this analysis population.

Response to treatment is defined as a complete response (CR) or partial response (PR) to treatment. Confirmation of response required a second assessment performed at least 4 weeks after the initial assessment. (PR is defined as at least a 30% reduction in sum of the longest diameter of all target lesions and no increase in non-target lesions).

Outcome measures

Measure	Vorinostat + Paclitaxel + Carboplatin n=125 Participants Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.	Placebo + Paclitaxel + Carboplatin n=123 Participants Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
Number of Participants Who Had a Disease Response to Treatment Responder	28 Participants	36 Participants
Number of Participants Who Had a Disease Response to Treatment Non-Responder	97 Participants	87 Participants

Adverse Events

Vorinostat + Paclitaxel + Carboplatin

Serious events: 63 serious events

Other events: 114 other events

Deaths: 0 deaths

Placebo + Paclitaxel + Carboplatin

Serious events: 45 serious events

Other events: 117 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vorinostat + Paclitaxel + Carboplatin n=124 participants at risk Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.	Placebo + Paclitaxel + Carboplatin n=124 participants at risk Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
Blood and lymphatic system disorders Anaemia	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	2.4% 3/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Blood and lymphatic system disorders Febrile neutropenia	8.1% 10/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Blood and lymphatic system disorders Neutropenia	7.3% 9/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Blood and lymphatic system disorders Thrombocytopenia	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Cardiac disorders Atrial fibrillation	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	2.4% 3/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Cardiac disorders Cardiac arrest	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Cardiac disorders Myocardial infarction	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Abdominal pain	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Abdominal pain upper	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Diarrhoea	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Rectal perforation	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Retching	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
General disorders Asthenia	4.8% 6/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
General disorders Death	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
General disorders Fatigue	2.4% 3/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
General disorders Multi-organ failure	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
General disorders Pyrexia	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Hepatobiliary disorders Cholecystitis	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Immune system disorders Hypersensitivity	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Infections and infestations Bacteraemia	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Infections and infestations Cellulitis	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Infections and infestations Gastroenteritis	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Infections and infestations Neutropenic sepsis	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Infections and infestations Pneumonia	8.9% 11/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	7.3% 9/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Infections and infestations Pulmonary sepsis	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Infections and infestations Sepsis	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Infections and infestations Septic shock	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Infections and infestations Staphylococcal infection	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Infections and infestations Upper respiratory tract infection	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Injury, poisoning and procedural complications Accidental overdose	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Injury, poisoning and procedural complications Femur fracture	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Injury, poisoning and procedural complications Overdose	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Injury, poisoning and procedural complications Procedural pain	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Investigations Troponin increased	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Anorexia	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Dehydration	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Hypercalcaemia	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Hypokalaemia	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Hypomagnesaemia	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Hyponatraemia	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Musculoskeletal and connective tissue disorders Arthralgia	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Musculoskeletal and connective tissue disorders Back pain	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	2.4% 3/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Musculoskeletal and connective tissue disorders Myalgia	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	6.5% 8/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	8.9% 11/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Nervous system disorders Cerebrovascular accident	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Nervous system disorders Convulsion	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Nervous system disorders Dizziness	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Nervous system disorders Headache	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Nervous system disorders Hemiparesis	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Nervous system disorders Syncope	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Renal and urinary disorders Azotaemia	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Renal and urinary disorders Haematuria	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Cough	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.4% 3/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.4% 3/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Skin and subcutaneous tissue disorders Dermatitis	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Vascular disorders Aortic thrombosis	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Vascular disorders Embolism	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Vascular disorders Hypotension	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Vascular disorders Peripheral ischaemia	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Vascular disorders Superior vena caval occlusion	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Vascular disorders Thrombosis	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.

Other adverse events

Measure	Vorinostat + Paclitaxel + Carboplatin n=124 participants at risk Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.	Placebo + Paclitaxel + Carboplatin n=124 participants at risk Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
Blood and lymphatic system disorders Anaemia	41.1% 51/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	33.9% 42/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Blood and lymphatic system disorders Leukopenia	10.5% 13/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	14.5% 18/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Blood and lymphatic system disorders Lymphopenia	7.3% 9/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	8.1% 10/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Blood and lymphatic system disorders Neutropenia	42.7% 53/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	44.4% 55/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Blood and lymphatic system disorders Thrombocytopenia	36.3% 45/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	18.5% 23/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Ear and labyrinth disorders Tinnitus	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Eye disorders Vision blurred	2.4% 3/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Abdominal distension	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Abdominal pain	7.3% 9/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	4.8% 6/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Abdominal pain upper	4.8% 6/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	4.8% 6/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Constipation	27.4% 34/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	21.0% 26/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Diarrhoea	34.7% 43/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	29.0% 36/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Dry mouth	5.6% 7/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Dyspepsia	6.5% 8/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	5.6% 7/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Dysphagia	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Gastritis	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Nausea	37.1% 46/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	31.5% 39/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Stomatitis	9.7% 12/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	8.9% 11/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Gastrointestinal disorders Vomiting	27.4% 34/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	19.4% 24/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
General disorders Asthenia	21.8% 27/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	14.5% 18/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
General disorders Chills	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
General disorders Fatigue	22.6% 28/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	25.8% 32/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
General disorders Oedema peripheral	8.9% 11/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	10.5% 13/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
General disorders Pyrexia	16.9% 21/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	8.9% 11/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Hepatobiliary disorders Hyperbilirubinaemia	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Infections and infestations Influenza	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Infections and infestations Pneumonia	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Infections and infestations Upper respiratory tract infection	6.5% 8/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	9.7% 12/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Infections and infestations Urinary tract infection	5.6% 7/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Investigations Alanine aminotransferase increased	8.1% 10/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	10.5% 13/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Investigations Aspartate aminotransferase increased	7.3% 9/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	7.3% 9/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Investigations Blood alkaline phosphatase increased	7.3% 9/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	5.6% 7/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Investigations Weight decreased	4.8% 6/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	8.1% 10/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Anorexia	27.4% 34/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	25.0% 31/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Decreased appetite	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	2.4% 3/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Dehydration	4.8% 6/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Hyperglycaemia	8.1% 10/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	6.5% 8/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Hyperkalaemia	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	2.4% 3/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Hypoalbuminaemia	9.7% 12/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	8.1% 10/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Hypocalcaemia	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	2.4% 3/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Hypoglycaemia	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Hypokalaemia	11.3% 14/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	8.1% 10/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Hypomagnesaemia	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	6.5% 8/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Metabolism and nutrition disorders Hyponatraemia	13.7% 17/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	9.7% 12/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Musculoskeletal and connective tissue disorders Arthralgia	12.9% 16/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	21.8% 27/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Musculoskeletal and connective tissue disorders Back pain	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	10.5% 13/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Musculoskeletal and connective tissue disorders Bone pain	9.7% 12/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	7.3% 9/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Musculoskeletal and connective tissue disorders Muscle spasms	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.5% 8/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Musculoskeletal and connective tissue disorders Myalgia	16.9% 21/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	29.0% 36/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Musculoskeletal and connective tissue disorders Pain in extremity	7.3% 9/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	7.3% 9/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	10.5% 13/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Nervous system disorders Dizziness	7.3% 9/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	9.7% 12/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Nervous system disorders Dysgeusia	8.9% 11/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	7.3% 9/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Nervous system disorders Headache	10.5% 13/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	9.7% 12/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Nervous system disorders Lethargy	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Nervous system disorders Peripheral motor neuropathy	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	2.4% 3/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Nervous system disorders Peripheral sensory neuropathy	41.1% 51/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	49.2% 61/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Nervous system disorders Tremor	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Psychiatric disorders Anxiety	4.8% 6/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	5.6% 7/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Psychiatric disorders Insomnia	15.3% 19/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	12.1% 15/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Renal and urinary disorders Dysuria	2.4% 3/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Cough	16.9% 21/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	16.1% 20/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Dysphonia	4.8% 6/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.9% 21/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	16.9% 21/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.5% 8/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	4.8% 6/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Hiccups	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Productive cough	4.8% 6/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	8.1% 10/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.4% 3/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	5.6% 7/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Skin and subcutaneous tissue disorders Alopecia	33.1% 41/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	37.9% 47/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Skin and subcutaneous tissue disorders Dry skin	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Skin and subcutaneous tissue disorders Erythema	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Skin and subcutaneous tissue disorders Pruritus	7.3% 9/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	8.1% 10/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Skin and subcutaneous tissue disorders Rash	14.5% 18/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	10.5% 13/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Vascular disorders Deep vein thrombosis	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	0.00% 0/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Vascular disorders Hypertension	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	4.0% 5/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Vascular disorders Hypotension	0.81% 1/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
Vascular disorders Thrombophlebitis superficial	3.2% 4/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.	1.6% 2/124 • Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution. The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Results disclosure agreements

• Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER