Trial Outcomes & Findings for A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia (NCT NCT01961882)
NCT ID: NCT01961882
Last Updated: 2021-03-26
Results Overview
Disease-free survival (DFS) was defined as the time from randomization until relapse or death from any cause, whichever came first, by the DFS-cutoff date.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
134 participants
Primary outcome timeframe
2 years (treatment period)
Results posted on
2021-03-26
Participant Flow
Of the 134 subjects randomized in this trial, one subject who was randomized but did not receive the investigational medicinal product (IMP) was excluded from all analysis data sets.
Participant milestones
| Measure |
OCV-501
3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
|
Placebo
Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
65
|
|
Overall Study
COMPLETED
|
19
|
23
|
|
Overall Study
NOT COMPLETED
|
50
|
42
|
Reasons for withdrawal
| Measure |
OCV-501
3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
|
Placebo
Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Relapse of AML
|
39
|
37
|
|
Overall Study
Use of prohibited concomitant drug or therapy
|
2
|
2
|
|
Overall Study
Subject found to be ineligible for the trial after registration
|
1
|
0
|
Baseline Characteristics
A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
OCV-501
n=68 Participants
3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
|
Placebo
n=65 Participants
Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
|
Total
n=133 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
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Continuous
|
68.3 years
STANDARD_DEVIATION 5.61 • n=5 Participants
|
68.6 years
STANDARD_DEVIATION 6.20 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 5.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
52 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years (treatment period)Population: FAS: all subjects who received the IMP at least once and from whom data on at least 1 efficacy endpoint were obtained after the start of IMP administration.
Disease-free survival (DFS) was defined as the time from randomization until relapse or death from any cause, whichever came first, by the DFS-cutoff date.
Outcome measures
| Measure |
OCV-501
n=68 Participants
3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
|
Placebo
n=65 Participants
Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
|
|---|---|---|
|
Disease-Free Survival
|
40.9 percentage of participants
Interval 28.2 to 53.2
|
41.4 percentage of participants
Interval 28.9 to 53.5
|
SECONDARY outcome
Timeframe: 2 years (treatment period)Population: FAS: all subjects who received the IMP at least once and from whom data on at least 1 efficacy endpoint were obtained after the start of IMP administration.
Subjects were surveyed for survival by the date of cutoff. The cutoff date was set as the date after 728 days (2 years) from the day that the last subject started IMP administration.
Outcome measures
| Measure |
OCV-501
n=68 Participants
3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
|
Placebo
n=65 Participants
Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
|
|---|---|---|
|
Overall Survival
|
60.3 percentage of participants
Interval 47.7 to 70.8
|
58.5 percentage of participants
Interval 45.6 to 69.3
|
Adverse Events
OCV-501
Serious events: 7 serious events
Other events: 67 other events
Deaths: 1 deaths
Placebo
Serious events: 7 serious events
Other events: 59 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
OCV-501
n=68 participants at risk
3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
|
Placebo
n=65 participants at risk
Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
|
|---|---|---|
|
Infections and infestations
Infectious colitis
|
1.5%
1/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
0.00%
0/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Infections and infestations
Sepsis
|
1.5%
1/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
0.00%
0/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
0.00%
0/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
1.5%
1/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Immune system disorders
Drug hypersensitivity
|
1.5%
1/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
0.00%
0/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Immune system disorders
Hypersensitivity
|
1.5%
1/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
0.00%
0/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Cardiac disorders
Stress cardiomyopathy
|
1.5%
1/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
0.00%
0/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Eye disorders
Retinal detachment
|
1.5%
1/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
0.00%
0/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.5%
1/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
1.5%
1/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
1.5%
1/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
1.5%
1/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
1.5%
1/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
1.5%
1/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Nervous system disorders
Hypoglycaemic encephalopathy
|
0.00%
0/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
1.5%
1/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
1.5%
1/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
1.5%
1/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
Other adverse events
| Measure |
OCV-501
n=68 participants at risk
3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
|
Placebo
n=65 participants at risk
Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
|
|---|---|---|
|
General disorders
Injection site induration
|
73.5%
50/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
29.2%
19/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
General disorders
Injection site erythema
|
45.6%
31/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
16.9%
11/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
General disorders
Injection site pruritus
|
29.4%
20/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
13.8%
9/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
General disorders
Injection site pain
|
26.5%
18/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
3.1%
2/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
General disorders
Pyrexia
|
14.7%
10/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
6.2%
4/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
General disorders
Injection site swelling
|
10.3%
7/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
3.1%
2/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
General disorders
Malaise
|
8.8%
6/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
3.1%
2/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
General disorders
Oedema peripheral
|
4.4%
3/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
6.2%
4/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Infections and infestations
Nasopharyngitis
|
26.5%
18/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
20.0%
13/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Infections and infestations
Upper respiratory tract infection
|
8.8%
6/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
10.8%
7/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Infections and infestations
Herpes zoster
|
5.9%
4/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
4.6%
3/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Infections and infestations
Pharyngitis
|
2.9%
2/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
9.2%
6/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Infections and infestations
Bronchitis
|
1.5%
1/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
6.2%
4/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.8%
8/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
12.3%
8/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.9%
4/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
1.5%
1/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.4%
3/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
6.2%
4/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
8/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
4.6%
3/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
5/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
3.1%
2/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
4/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
1.5%
1/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Gastrointestinal disorders
Diarrhoea
|
10.3%
7/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
7.7%
5/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Gastrointestinal disorders
Stomatitis
|
2.9%
2/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
10.8%
7/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Investigations
Platelet count decreased
|
10.3%
7/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
13.8%
9/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Investigations
Neutrophil count decreased
|
1.5%
1/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
7.7%
5/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Headache
|
7.4%
5/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
3.1%
2/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
5/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
3.1%
2/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
4/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
4.6%
3/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Injury, poisoning and procedural complications
Contusion
|
2.9%
2/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
6.2%
4/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Psychiatric disorders
Insomnia
|
2.9%
2/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
6.2%
4/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/68 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
6.2%
4/65 • Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Phone: +81-3-6361-7366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place