Trial Outcomes & Findings for Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL (NCT NCT01728805)

NCT ID: NCT01728805

Last Updated: 2024-04-25

Results Overview

Progression was defined as follows, based on Olsen (2011): * Lymph nodes: ≥ 50% increase in SPD from baseline of lymph nodes, any new node \> 1.5 cm in the long axis or \> 1 cm in the short axis if 1-1.5 cm in the long axis that is proven to be N3 histologically, or \> 50% increase from nadir in SPD of lymph nodes in those with PR * Skin: ≥ 25% increase in skin disease from baseline, new tumors (T3) in patients with T1, T2 or T4 only skin disease, or in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score * Blood: B0 to B2, \> 50% increase from baseline and at least 5,000 neoplastic cells/μL36, or \> 50% increase from nadir and at least 5,000 neoplastic cells/μL * Viscera: \> 50% increase in size (SPD) of any organs involved at baseline, new organ involvement, or \> 50% increase from nadir in the size (SPD) of any previous organ involvement in those with PR

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

372 participants

Primary outcome timeframe

From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Results posted on

2024-04-25

Participant Flow

Participant milestones

Participant milestones
Measure
KW-0761
anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Vorinostat
vorinostat 400 mg once daily Vorinostat
Vorinostat Original Then Crossover to KW-0761
Subjects who were randomized to vorinostat could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor.
Randomization Period
STARTED
186
186
0
Randomization Period
COMPLETED
186
186
0
Randomization Period
NOT COMPLETED
0
0
0
Crossover Period
STARTED
0
0
136
Crossover Period
COMPLETED
0
0
136
Crossover Period
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
KW-0761
n=186 Participants
anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Vorinostat
n=186 Participants
vorinostat 400 mg once daily Vorinostat
Total
n=372 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
99 Participants
n=5 Participants
89 Participants
n=7 Participants
188 Participants
n=5 Participants
Age, Categorical
>=65 years
87 Participants
n=5 Participants
97 Participants
n=7 Participants
184 Participants
n=5 Participants
Age, Continuous
62.8 years
n=5 Participants
63.3 years
n=7 Participants
63.0 years
n=5 Participants
Sex: Female, Male
Female
77 Participants
n=5 Participants
79 Participants
n=7 Participants
156 Participants
n=5 Participants
Sex: Female, Male
Male
109 Participants
n=5 Participants
107 Participants
n=7 Participants
216 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · White
125 Participants
n=5 Participants
135 Participants
n=7 Participants
260 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Other
37 Participants
n=5 Participants
26 Participants
n=7 Participants
63 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Not Reported
24 Participants
n=5 Participants
25 Participants
n=7 Participants
49 Participants
n=5 Participants
Region of Enrollment
Netherlands
0 participants
n=5 Participants
2 participants
n=7 Participants
2 participants
n=5 Participants
Region of Enrollment
United States
98 participants
n=5 Participants
103 participants
n=7 Participants
201 participants
n=5 Participants
Region of Enrollment
Japan
9 participants
n=5 Participants
6 participants
n=7 Participants
15 participants
n=5 Participants
Region of Enrollment
Denmark
1 participants
n=5 Participants
2 participants
n=7 Participants
3 participants
n=5 Participants
Region of Enrollment
Italy
14 participants
n=5 Participants
12 participants
n=7 Participants
26 participants
n=5 Participants
Region of Enrollment
United Kingdom
16 participants
n=5 Participants
14 participants
n=7 Participants
30 participants
n=5 Participants
Region of Enrollment
France
23 participants
n=5 Participants
24 participants
n=7 Participants
47 participants
n=5 Participants
Region of Enrollment
Australia
9 participants
n=5 Participants
7 participants
n=7 Participants
16 participants
n=5 Participants
Region of Enrollment
Switzerland
2 participants
n=5 Participants
2 participants
n=7 Participants
4 participants
n=5 Participants
Region of Enrollment
Germany
5 participants
n=5 Participants
6 participants
n=7 Participants
11 participants
n=5 Participants
Region of Enrollment
Spain
9 participants
n=5 Participants
8 participants
n=7 Participants
17 participants
n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Progression was defined as follows, based on Olsen (2011): * Lymph nodes: ≥ 50% increase in SPD from baseline of lymph nodes, any new node \> 1.5 cm in the long axis or \> 1 cm in the short axis if 1-1.5 cm in the long axis that is proven to be N3 histologically, or \> 50% increase from nadir in SPD of lymph nodes in those with PR * Skin: ≥ 25% increase in skin disease from baseline, new tumors (T3) in patients with T1, T2 or T4 only skin disease, or in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score * Blood: B0 to B2, \> 50% increase from baseline and at least 5,000 neoplastic cells/μL36, or \> 50% increase from nadir and at least 5,000 neoplastic cells/μL * Viscera: \> 50% increase in size (SPD) of any organs involved at baseline, new organ involvement, or \> 50% increase from nadir in the size (SPD) of any previous organ involvement in those with PR

Outcome measures

Outcome measures
Measure
KW-0761
n=186 Participants
anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Vorinostat
n=186 Participants
vorinostat 400 mg once daily Vorinostat
Progression Free Survival
Rate (%) of Being Alive w/o Progression at 6 mos.
55.3 percentage of subjects
Interval 47.1 to 62.6
28.8 percentage of subjects
Interval 21.6 to 36.3
Progression Free Survival
Rate (%) of Being Alive w/o Progression at 12 mos.
38.3 percentage of subjects
Interval 30.2 to 46.4
15.3 percentage of subjects
Interval 9.5 to 22.3
Progression Free Survival
Rate (%) of Being Alive w/o Progression at 18 mos.
28.0 percentage of subjects
Interval 19.8 to 36.8
7.2 percentage of subjects
Interval 2.7 to 14.5
Progression Free Survival
Rate (%) of Being Alive w/o Progression at 24 mos.
14.1 percentage of subjects
Interval 6.4 to 24.8
7.2 percentage of subjects
Interval 2.7 to 14.5
Progression Free Survival
Rate (%) of Being Alive w/o Progression at 30 mos.
4.7 percentage of subjects
Interval 0.5 to 17.7
7.2 percentage of subjects
Interval 2.7 to 14.5

SECONDARY outcome

Timeframe: at the end of cycle 1 (26-28 days), and then every other cycle in Year 1 (cycle 3, 5, 7, 9, 11, 13), and every 16 weeks (cycle 17, 21, etc.) in Year 2 and beyond until progression up to 36 months

Population: The total number of patients analyzed are further broken out by disease type \[mycosis fungoides (MF) and Sezary Syndrome (SS)\]

The ORR was defined as the count of subjects who had a confirmed CR or PR, defined as documented CR or PR per Global Composite Response Score that was confirmed by a subsequent observation at least 4 weeks later. Overall Response Rate was determined based on the response in all compartments (lymph nodes, skin, peripheral blood, and viscera), referencing Olsen, 2011 as follows: Complete Response (CR) = complete disappearance of all clinical evidence of disease; Partial Response (PR) = regression of measurable disease; Stable Disease (SD) = failure to attain CR, PR, or PD; Progressive Disease (PD) = PD in any compartment; Relapse = recurrence of disease in prior CR in any compartment.

Outcome measures

Outcome measures
Measure
KW-0761
n=186 Participants
anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Vorinostat
n=186 Participants
vorinostat 400 mg once daily Vorinostat
Overall Response Rate
All Subjects ORR (confirmed CR + PR)
52 Participants
9 Participants
Overall Response Rate
Disease Type = MF ORR (confirmed CR + PR)
22 Participants
7 Participants
Overall Response Rate
Disease Type = SS ORR (confirmed CR + PR)
30 Participants
2 Participants

SECONDARY outcome

Timeframe: Cycle 1, 3, and 5

Population: The number of subjects analyzed in each row is the number of subjects with values at baseline and the specified post-baseline timepoint.

* Skindex-29 rates 29 items assessing 3 domains (emotions, symptoms, \& functioning) on a linear scale from 0 (never) to all the time (100). Higher scores = higher impact of skin disease. * FACT-G rates 27 items in 4 domains (physical well-being, social/family well-being, emotional well-being, functional well-being) on a 5-point scale from 0 (not at all) to 4 (very much). Higher scores = better QoL. * EuroQoL lvl 3 (Eq-5D-3L) rates mobility, self-care, usual activities, pain/discomfort and anxiety/depression on 3 levels - no problems, some problems, extreme problems. Score is calculated using a set of item weights to derive a single score ranging from -0.109 to 1, with 1 representing full health. LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate.

Outcome measures

Outcome measures
Measure
KW-0761
n=186 Participants
anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Vorinostat
n=186 Participants
vorinostat 400 mg once daily Vorinostat
Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score
Skindex-29 Across 6-month Assessment
-12.6 score on a scale
Interval -15.94 to -9.29
-6.0 score on a scale
Interval -9.39 to -2.52
Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score
FACT-G Across 6-month Assessment
4.6 score on a scale
Interval 2.14 to 7.04
-2.3 score on a scale
Interval -4.84 to 0.21
Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score
EQ-5D-3L Across 6-month Assessment
0.06 score on a scale
Interval 0.028 to 0.085
0.02 score on a scale
Interval -0.008 to 0.052

SECONDARY outcome

Timeframe: Cycle 1, 3, and 5

Population: The number of participants analyzed were subjects with values at baseline and post-baseline.

The Itchy QoL is a validated pruritus specific quality of life instrument. It includes 22 pruritus-specific questions covering three major domains: symptoms, functioning, and emotions. The scale ranges from Never (1) to All The Time (5). The subscale scores consist of the average of the responses to the items in a given subscale. The overall score is the average of the responses to all items. Higher Itchy QoL scores indicate worse quality of life. LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate.

Outcome measures

Outcome measures
Measure
KW-0761
n=166 Participants
anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Vorinostat
n=175 Participants
vorinostat 400 mg once daily Vorinostat
Pruritis Evaluation
-0.5 score on a scale
Interval -0.66 to -0.39
-0.4 score on a scale
Interval -0.52 to -0.24

Adverse Events

KW-0761

Serious events: 69 serious events
Other events: 178 other events
Deaths: 40 deaths

Vorinostat

Serious events: 46 serious events
Other events: 182 other events
Deaths: 47 deaths

Vorinostat Original Then Crossover to KW-0761

Serious events: 40 serious events
Other events: 128 other events
Deaths: 32 deaths

Serious adverse events

Serious adverse events
Measure
KW-0761
n=184 participants at risk
anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Vorinostat
n=186 participants at risk
vorinostat 400 mg once daily Vorinostat
Vorinostat Original Then Crossover to KW-0761
n=135 participants at risk
Subjects who were randomized to vorinostat could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor.
Blood and lymphatic system disorders
Anaemia
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Blood and lymphatic system disorders
Anaemia Haemolytic Autoimmune
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Blood and lymphatic system disorders
Febrile Neutropenia
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Blood and lymphatic system disorders
Haemolytic Anaemia
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.1%
2/186 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.6%
3/186 • Number of events 4 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Cardiac disorders
Acute Myocardial Infarction
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Cardiac disorders
Angina Pectoris
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Cardiac disorders
Angina Unstable
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Cardiac disorders
Atrial Fibrillation
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Cardiac disorders
Cardiac Failure
0.54%
1/184 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Cardiac disorders
Left Ventricular Hypertrophy
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Cardiac disorders
Myocarditis
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Cardiac disorders
Supraventricular Tachycardia
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Ear and labyrinth disorders
Ear Pain
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Eye disorders
Lens Dislocation
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Eye disorders
Retinal Vein Occlusion
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Abdominal Pain
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Abdominal Pain Upper
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Anal Fistula
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Colitis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Constipation
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Diarrhoea
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Gastric Haemorrhage
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Gastrointestinal Haemorrhage
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Ileitis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Inguinal Hernia
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Intestinal Obstruction
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Large Intestinal Ulcer Haemorrhage
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Lip Swelling
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Nausea
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Stomatitis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 3 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Vomiting
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Asthenia
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.1%
2/186 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Chest Discomfort
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Chest Pain
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.5%
2/135 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Death
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Device Failure
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Disease Progression
2.2%
4/184 • Number of events 4 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Facial Pain
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Fatigue
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
General Physical Health Deterioration
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Hypothermia
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Localised Oedema
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Oedema
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Oedema Peripheral
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.5%
2/135 • Number of events 3 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Pyrexia
4.3%
8/184 • Number of events 9 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.5%
2/135 • Number of events 5 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Hepatobiliary disorders
Autoimmune Hepatitis
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Hepatobiliary disorders
Cholangitis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Hepatobiliary disorders
Cholecystitis Acute
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Hepatobiliary disorders
Hepatic Failure
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Hepatobiliary disorders
Hepatitis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Hepatobiliary disorders
Hepatitis Acute
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Hepatobiliary disorders
Hepatocellular Injury
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Immune system disorders
Contrast Media Allergy
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Immune system disorders
Drug Hypersensitivity
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Immune system disorders
Hypersensitivity
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Abscess Limb
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Appendicitis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Arthritis Bacterial
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Atypical Pneumonia
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Bacteraemia
1.1%
2/184 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Bronchitis
1.1%
2/184 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Bronchopneumonia
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Cellulitis
2.7%
5/184 • Number of events 5 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
3.2%
6/186 • Number of events 6 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
2.2%
3/135 • Number of events 3 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Cytomegalovirus Infection
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Device Related Infection
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.5%
2/135 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Diverticulitis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Endocarditis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Enterovirus Infection
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Epstein-Barr Virus Infection
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Gastroenteritis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Herpes Simplex
1.1%
2/184 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Herpes Zoster
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Influenza
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Lower Respiratory Tract Infection
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Meningitis
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Osteomyelitis
1.1%
2/184 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Otitis Externa
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Periorbital Cellulitis
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Pharyngitis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Pneumocystis Jiroveci Pneumonia
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Pneumonia
2.2%
4/184 • Number of events 4 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.1%
2/186 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.5%
2/135 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Pneumonia Influenzal
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Pneumonia Legionella
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Pneumonia Pneumococcal
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Postoperative Wound Infection
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Respiratory Tract Infection
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Rhinovirus Infection
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Sepsis
1.6%
3/184 • Number of events 4 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
2.7%
5/186 • Number of events 5 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.5%
2/135 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Sepsis Syndrome
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Septic Embolus
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Septic Shock
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Skin Infection
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.6%
3/186 • Number of events 3 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Staphylococcal Abscess
0.54%
1/184 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Staphylococcal Bacteraemia
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Staphylococcal Infection
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Staphylococcal Sepsis
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Superinfection
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Upper Respiratory Tract Infection
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.1%
2/186 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Urinary Tract Infection
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Urinary Tract Infection Bacterial
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Viral Infection
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Wound Infection
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Injury, poisoning and procedural complications
Fall
1.1%
2/184 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Injury, poisoning and procedural complications
Femur Fracture
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.5%
2/135 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Injury, poisoning and procedural complications
Infusion Related Reaction
1.6%
3/184 • Number of events 3 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
3.0%
4/135 • Number of events 4 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Injury, poisoning and procedural complications
Laceration
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Injury, poisoning and procedural complications
Lower Limb Fracture
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Injury, poisoning and procedural complications
Pelvic Fracture
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Injury, poisoning and procedural complications
Subdural Haematoma
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Injury, poisoning and procedural complications
Subdural Haemorrhage
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Injury, poisoning and procedural complications
Vascular Access Complication
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Investigations
Alanine Aminotransferase Increased
1.1%
2/184 • Number of events 3 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Investigations
Aspartate Aminotransferase Increased
1.1%
2/184 • Number of events 3 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Investigations
Blood Alkaline Phospatase Increased
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Investigations
Blood Creatinine Increased
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Metabolism and nutrition disorders
Decreased Appetite
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Metabolism and nutrition disorders
Dehydration
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Metabolism and nutrition disorders
Gout
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Metabolism and nutrition disorders
Hypercalcaemia
1.6%
3/184 • Number of events 3 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Metabolism and nutrition disorders
Metabolic Acidosis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Arthralgia
1.1%
2/184 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Back Pain
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Monarthritis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Muscular Weakness
0.54%
1/184 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Myositis
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Polymyositis
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's Disease
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected Neoplasm
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Pleural Effusion
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Lymph Nodes
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis Fungoides
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 3 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Nervous system disorders
Depressed Level of Consciousness
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Nervous system disorders
Haemorrhage Intracranial
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Nervous system disorders
Hepatic Encephalopathy
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Nervous system disorders
Metabolic Encephalopathy
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Nervous system disorders
Miller Fisher Syndrome
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Nervous system disorders
Monoparesis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Nervous system disorders
Motor Dysfunction
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Psychiatric disorders
Confusional State
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Psychiatric disorders
Depression
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Psychiatric disorders
Mental Status Changes
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Renal and urinary disorders
Haematuria
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Renal and urinary disorders
Renal Failure
0.54%
1/184 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Renal and urinary disorders
Renal Failure Acute
1.1%
2/184 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Renal and urinary disorders
Renal Impairment
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Renal and urinary disorders
Urinary Retention
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Reproductive system and breast disorders
Oedema Genital
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
2.7%
5/186 • Number of events 5 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
1.1%
2/184 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Skin and subcutaneous tissue disorders
Drug Eruption
1.1%
2/184 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Skin and subcutaneous tissue disorders
Pruritis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Skin and subcutaneous tissue disorders
Skin Disorder
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Social circumstances
Social Stay Hospitalization
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Surgical and medical procedures
Cardiac Pacemaker Replacement
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Vascular disorders
Air Embolism
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Vascular disorders
Aortic Stenosis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.74%
1/135 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Vascular disorders
Embolism
1.1%
2/184 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Vascular disorders
Peripheral Arterial Occlusive Disease
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Vascular disorders
Phlebitis
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.

Other adverse events

Other adverse events
Measure
KW-0761
n=184 participants at risk
anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Vorinostat
n=186 participants at risk
vorinostat 400 mg once daily Vorinostat
Vorinostat Original Then Crossover to KW-0761
n=135 participants at risk
Subjects who were randomized to vorinostat could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor.
Blood and lymphatic system disorders
Anaemia
10.9%
20/184 • Number of events 35 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
9.7%
18/186 • Number of events 20 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
6.7%
9/135 • Number of events 10 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.2%
7/135 • Number of events 8 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Blood and lymphatic system disorders
Thrombocytopenia
11.4%
21/184 • Number of events 34 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
30.1%
56/186 • Number of events 83 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
8.1%
11/135 • Number of events 48 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Eye disorders
Dry Eye
3.8%
7/184 • Number of events 7 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.9%
11/186 • Number of events 11 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Eye disorders
Vision Blurred
4.3%
8/184 • Number of events 9 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
6.5%
12/186 • Number of events 14 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Abdominal Pain
3.8%
7/184 • Number of events 8 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
11.3%
21/186 • Number of events 24 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.2%
7/135 • Number of events 7 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Abdominal Pain Upper
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.9%
11/186 • Number of events 12 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Constipation
12.5%
23/184 • Number of events 27 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
18.3%
34/186 • Number of events 37 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
11.1%
15/135 • Number of events 15 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Diarrhoea
24.5%
45/184 • Number of events 62 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
61.3%
114/186 • Number of events 180 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
16.3%
22/135 • Number of events 33 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Dry Mouth
2.2%
4/184 • Number of events 4 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
9.1%
17/186 • Number of events 17 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Dyspepsia
0.54%
1/184 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.9%
11/186 • Number of events 11 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Nausea
15.8%
29/184 • Number of events 38 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
41.9%
78/186 • Number of events 99 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
7.4%
10/135 • Number of events 13 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Stomatitis
5.4%
10/184 • Number of events 16 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.1%
2/186 • Number of events 3 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Gastrointestinal disorders
Vomiting
6.5%
12/184 • Number of events 13 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
12.4%
23/186 • Number of events 33 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Asthenia
5.4%
10/184 • Number of events 12 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
13.4%
25/186 • Number of events 32 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
8.1%
11/135 • Number of events 18 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Chills
7.1%
13/184 • Number of events 17 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
7.5%
14/186 • Number of events 15 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.9%
8/135 • Number of events 8 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Fatigue
23.9%
44/184 • Number of events 55 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
37.1%
69/186 • Number of events 75 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
10.4%
14/135 • Number of events 19 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Oedema Peripheral
14.7%
27/184 • Number of events 32 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
14.0%
26/186 • Number of events 37 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
9.6%
13/135 • Number of events 16 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
General disorders
Pyrexia
14.1%
26/184 • Number of events 28 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.9%
11/186 • Number of events 11 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
12.6%
17/135 • Number of events 25 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Bronchitis
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
6.7%
9/135 • Number of events 12 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Folliculitis
7.6%
14/184 • Number of events 19 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
2.2%
4/186 • Number of events 4 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
9.6%
13/135 • Number of events 18 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Nasopharyngitis
7.1%
13/184 • Number of events 19 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
8.6%
16/186 • Number of events 23 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
6.7%
9/135 • Number of events 12 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Oral Candidasis
5.4%
10/184 • Number of events 10 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 1 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Skin Infection
9.2%
17/184 • Number of events 28 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.4%
10/186 • Number of events 15 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Upper Respiratory Tract Infection
10.9%
20/184 • Number of events 28 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
4.3%
8/186 • Number of events 9 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
8.9%
12/135 • Number of events 22 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Infections and infestations
Urinary Tract Infection
7.1%
13/184 • Number of events 17 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
7.5%
14/186 • Number of events 20 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.2%
7/135 • Number of events 8 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Injury, poisoning and procedural complications
Fall
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.9%
8/135 • Number of events 8 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Injury, poisoning and procedural complications
Infusion Related Reaction
32.1%
59/184 • Number of events 83 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
34.8%
47/135 • Number of events 55 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Investigations
Alanine Aminotransferase Increased
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
8.9%
12/135 • Number of events 13 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Investigations
Aspartate Aminotransferase Increased
3.8%
7/184 • Number of events 8 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
6.5%
12/186 • Number of events 19 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
9.6%
13/135 • Number of events 15 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Investigations
Blood Creatinine Increased
3.3%
6/184 • Number of events 9 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
28.0%
52/186 • Number of events 58 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Investigations
Platelet Count Decreased
2.2%
4/184 • Number of events 6 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
10.2%
19/186 • Number of events 22 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Investigations
Weight Decreased
6.0%
11/184 • Number of events 15 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
17.2%
32/186 • Number of events 35 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
6.7%
9/135 • Number of events 9 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Investigations
Weight Increased
8.2%
15/184 • Number of events 17 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
1.1%
2/186 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Metabolism and nutrition disorders
Decreased Appetite
7.6%
14/184 • Number of events 14 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
24.2%
45/186 • Number of events 49 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Metabolism and nutrition disorders
Hyperglycaemia
8.2%
15/184 • Number of events 29 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
7.0%
13/186 • Number of events 28 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Metabolism and nutrition disorders
Hypokalaemia
6.0%
11/184 • Number of events 15 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.9%
11/186 • Number of events 16 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Arthralgia
7.1%
13/184 • Number of events 14 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.9%
11/186 • Number of events 17 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
11.1%
15/135 • Number of events 17 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Back Pain
9.2%
17/184 • Number of events 20 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
4.8%
9/186 • Number of events 10 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
7.4%
10/135 • Number of events 13 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Muscle Spasms
5.4%
10/184 • Number of events 11 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
15.6%
29/186 • Number of events 49 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Muscular Weakness
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.2%
7/135 • Number of events 7 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Myalgia
6.5%
12/184 • Number of events 14 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
4.3%
8/186 • Number of events 8 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Musculoskeletal and connective tissue disorders
Pain In Extremity
7.1%
13/184 • Number of events 17 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.4%
10/186 • Number of events 16 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
9.6%
13/135 • Number of events 13 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Nervous system disorders
Dizziness
6.5%
12/184 • Number of events 13 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
10.2%
19/186 • Number of events 20 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.9%
8/135 • Number of events 11 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Nervous system disorders
Dysgeusia
4.3%
8/184 • Number of events 8 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
29.6%
55/186 • Number of events 59 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Nervous system disorders
Headache
12.5%
23/184 • Number of events 35 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
14.5%
27/186 • Number of events 32 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
12.6%
17/135 • Number of events 32 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Nervous system disorders
Paraesthesia
2.7%
5/184 • Number of events 5 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
7.5%
14/186 • Number of events 16 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.9%
8/135 • Number of events 10 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Psychiatric disorders
Depression
5.4%
10/184 • Number of events 10 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
3.2%
6/186 • Number of events 6 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Psychiatric disorders
Insomnia
8.7%
16/184 • Number of events 16 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
7.5%
14/186 • Number of events 14 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Respiratory, thoracic and mediastinal disorders
Cough
9.8%
18/184 • Number of events 20 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
8.6%
16/186 • Number of events 19 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
6.7%
9/135 • Number of events 9 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
5.4%
10/184 • Number of events 14 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
3.8%
7/186 • Number of events 8 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
6.0%
11/184 • Number of events 11 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
2.7%
5/186 • Number of events 7 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.2%
7/135 • Number of events 8 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Skin and subcutaneous tissue disorders
Alopecia
7.1%
13/184 • Number of events 13 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
18.8%
35/186 • Number of events 35 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
6.7%
9/135 • Number of events 9 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Skin and subcutaneous tissue disorders
Drug Eruption
23.9%
44/184 • Number of events 77 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.54%
1/186 • Number of events 2 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
25.9%
35/135 • Number of events 54 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Skin and subcutaneous tissue disorders
Intertrigo
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
5.2%
7/135 • Number of events 12 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/184 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/186 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
8.1%
11/135 • Number of events 15 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Vascular disorders
Hypertension
9.2%
17/184 • Number of events 38 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
13.4%
25/186 • Number of events 28 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
0.00%
0/135 • All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184. One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.

Additional Information

Fiona Herr, Associate Director, Medical Communications

Kyowa Kirin Inc

Phone: 1 (908) 234-1096

Results disclosure agreements

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