Trial Outcomes & Findings for Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients (NCT NCT00590187)
NCT ID: NCT00590187
Last Updated: 2024-06-04
Results Overview
Percentage of patients alive for one year measured from the date of randomization
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
up to 12 months from date of randomization
Results posted on
2024-06-04
Participant Flow
Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
Participant milestones
| Measure |
A Sapacitabine
200 mg b.i.d. x 7 days every 3-4 weeks
Sapacitabine, Arm A: 200 mg b.i.d. x 7 days every 3-4 weeks
|
B Sapacitabine
300 mg b.i.d. x 7 days every 3 - 4 weeks
Sapacitabine, Arm B: 300 mg b.i.d. x 7 days every 3 - 4 weeks
|
C Sapacitabine
400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
Sapacitabine, Arm C: 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
45
|
|
Overall Study
COMPLETED
|
40
|
20
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients
Baseline characteristics by cohort
| Measure |
A Sapacitabine
n=40 Participants
Sapacitabine, Arm A: 200 mg b.i.d. x 7 days every 3-4 weeks
|
B Sapacitabine
n=20 Participants
Sapacitabine, Arm B: 300 mg b.i.d. x 7 days every 3 - 4 weeks
|
C Sapacitabine
n=45 Participants
Sapacitabine, Arm C: 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
105 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
61 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
37 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
94 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Patients aged 70 years or higher
|
40 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
105 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: up to 12 months from date of randomizationPopulation: Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
Percentage of patients alive for one year measured from the date of randomization
Outcome measures
| Measure |
A Sapacitabine
n=20 Participants
200 mg b.i.d. x 7 days every 3-4 weeks
Sapacitabine, Arm A: 200 mg b.i.d. x 7 days every 3-4 weeks
|
B Sapacitabine
n=20 Participants
300 mg b.i.d. x 7 days every 3 - 4 weeks
Sapacitabine, Arm B: 300 mg b.i.d. x 7 days every 3 - 4 weeks
|
C Sapacitabine
n=20 Participants
400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
Sapacitabine, Arm C: 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
|
|---|---|---|---|
|
Survival
|
35 percentage of patients alive for one yea
Interval 16.0 to 59.0
|
10 percentage of patients alive for one yea
Interval 2.0 to 33.0
|
30 percentage of patients alive for one yea
Interval 13.0 to 54.0
|
SECONDARY outcome
Timeframe: From date of randomization until study withdrawal or death assessed up to 6 monthsPopulation: Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
Complete remission and complete remission without blood count recovery, transfusion requirements, hospitalized days and safety
Outcome measures
| Measure |
A Sapacitabine
n=40 Participants
200 mg b.i.d. x 7 days every 3-4 weeks
Sapacitabine, Arm A: 200 mg b.i.d. x 7 days every 3-4 weeks
|
B Sapacitabine
n=20 Participants
300 mg b.i.d. x 7 days every 3 - 4 weeks
Sapacitabine, Arm B: 300 mg b.i.d. x 7 days every 3 - 4 weeks
|
C Sapacitabine
n=45 Participants
400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
Sapacitabine, Arm C: 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
|
|---|---|---|---|
|
CR and CRp
|
6 Participants
|
2 Participants
|
8 Participants
|
Adverse Events
A Sapacitabine
Serious events: 40 serious events
Other events: 40 other events
Deaths: 8 deaths
B Sapacitabine
Serious events: 20 serious events
Other events: 20 other events
Deaths: 6 deaths
C Sapacitabine
Serious events: 45 serious events
Other events: 45 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
A Sapacitabine
n=40 participants at risk
200 mg b.i.d. x 7 days every 3-4 weeks
Sapacitabine, Arm A: 200 mg b.i.d. x 7 days every 3-4 weeks
|
B Sapacitabine
n=20 participants at risk
300 mg b.i.d. x 7 days every 3 - 4 weeks
Sapacitabine, Arm B: 300 mg b.i.d. x 7 days every 3 - 4 weeks
|
C Sapacitabine
n=45 participants at risk
400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
Sapacitabine, Arm C: 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
|
|---|---|---|---|
|
General disorders
Arthralgia
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
2.2%
1/45 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Back pain
|
5.0%
2/40 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/45 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Musculoskeletal chest pain
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
4.4%
2/45 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
8/40 • Number of events 8 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
60.0%
12/20 • Number of events 12 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
33.3%
15/45 • Number of events 15 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
40.0%
16/40 • Number of events 16 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
45.0%
9/20 • Number of events 9 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
48.9%
22/45 • Number of events 22 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Blood and lymphatic system disorders
Neutropenia
|
35.0%
14/40 • Number of events 14 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
50.0%
10/20 • Number of events 10 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
24.4%
11/45 • Number of events 11 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Blood and lymphatic system disorders
Throbocytopenia
|
60.0%
24/40 • Number of events 24 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
60.0%
12/20 • Number of events 12 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
48.9%
22/45 • Number of events 22 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Cardiac disorders
Atrial fibrilation
|
5.0%
2/40 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
10.0%
2/20 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
8.9%
4/45 • Number of events 4 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
4/40 • Number of events 4 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
4.4%
2/45 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
5.0%
1/20 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/45 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
2/40 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
10.0%
2/20 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
6.7%
3/45 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
4.4%
2/45 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
2.2%
1/45 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Fatigue
|
7.5%
3/40 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
5.0%
1/20 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
8.9%
4/45 • Number of events 4 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Peripheral Oedema
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
4.4%
2/45 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
15.0%
3/20 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/45 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Fever
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/45 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Infections and infestations
Bacteraemia
|
12.5%
5/40 • Number of events 5 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
10.0%
2/20 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
11.1%
5/45 • Number of events 5 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Cellulitis
|
7.5%
3/40 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
15.0%
3/20 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
11.1%
5/45 • Number of events 5 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
22.5%
9/40 • Number of events 9 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
30.0%
6/20 • Number of events 6 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
28.9%
13/45 • Number of events 13 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Sepsis
|
22.5%
9/40 • Number of events 9 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
15.0%
3/20 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
4.4%
2/45 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Anorexia
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/45 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Weight decreased
|
0.00%
0/40 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
2.2%
1/45 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Renal and urinary disorders
Hypokalemia
|
5.0%
2/40 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
5.0%
1/20 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
6.7%
3/45 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Headache
|
0.00%
0/40 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
6.7%
3/45 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Insomnia
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/45 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Dyspnoea
|
5.0%
2/40 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
4.4%
2/45 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Epistaxis
|
0.00%
0/40 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
5.0%
1/20 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/45 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Ecchymosis
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
5.0%
1/20 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
2.2%
1/45 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Petechiae
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/45 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
5.0%
1/20 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
2.2%
1/45 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Hypotension
|
5.0%
2/40 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
8.9%
4/45 • Number of events 4 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
Other adverse events
| Measure |
A Sapacitabine
n=40 participants at risk
200 mg b.i.d. x 7 days every 3-4 weeks
Sapacitabine, Arm A: 200 mg b.i.d. x 7 days every 3-4 weeks
|
B Sapacitabine
n=20 participants at risk
300 mg b.i.d. x 7 days every 3 - 4 weeks
Sapacitabine, Arm B: 300 mg b.i.d. x 7 days every 3 - 4 weeks
|
C Sapacitabine
n=45 participants at risk
400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
Sapacitabine, Arm C: 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
4/40 • Number of events 4 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
8.9%
4/45 • Number of events 4 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Cardiac disorders
Atrial fibrilation
|
5.0%
2/40 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
10.0%
2/20 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
4.4%
2/45 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Abdominal pain
|
15.0%
6/40 • Number of events 6 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
15.0%
3/20 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
2.2%
1/45 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
10/40 • Number of events 10 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
40.0%
8/20 • Number of events 8 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
24.4%
11/45 • Number of events 11 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Gastrointestinal disorders
Diarrhoea
|
57.5%
23/40 • Number of events 23 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
55.0%
11/20 • Number of events 11 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
37.8%
17/45 • Number of events 17 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Nausea
|
40.0%
16/40 • Number of events 16 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
30.0%
6/20 • Number of events 6 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
51.1%
23/45 • Number of events 23 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Stomatitis
|
10.0%
4/40 • Number of events 4 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
10.0%
2/20 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
15.6%
7/45 • Number of events 7 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Vomiting
|
30.0%
12/40 • Number of events 12 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
25.0%
5/20 • Number of events 5 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
24.4%
11/45 • Number of events 11 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Fatigue
|
47.5%
19/40 • Number of events 19 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
50.0%
10/20 • Number of events 10 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
28.9%
13/45 • Number of events 13 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Peripheral Oedema
|
12.5%
5/40 • Number of events 5 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
40.0%
8/20 • Number of events 8 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
33.3%
15/45 • Number of events 15 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
10.0%
2/20 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/45 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Fever
|
15.0%
6/40 • Number of events 6 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
5.0%
1/20 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
20.0%
9/45 • Number of events 9 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Bacteraemia
|
5.0%
2/40 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
5.0%
1/20 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/45 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Cellulitis
|
7.5%
3/40 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
6.7%
3/45 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
5.0%
1/20 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
2.2%
1/45 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Anorexia
|
22.5%
9/40 • Number of events 9 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
25.0%
5/20 • Number of events 5 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
17.8%
8/45 • Number of events 8 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Weight decrease
|
7.5%
3/40 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
20.0%
4/20 • Number of events 4 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
6.7%
3/45 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Renal and urinary disorders
Hypokalemia
|
7.5%
3/40 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
8.9%
4/45 • Number of events 4 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Arthralgia
|
17.5%
7/40 • Number of events 7 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
11.1%
5/45 • Number of events 5 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Back Pain
|
10.0%
4/40 • Number of events 4 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
5.0%
1/20 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
13.3%
6/45 • Number of events 6 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Musculoskeletal chest pain
|
2.5%
1/40 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
13.3%
6/45 • Number of events 6 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Pain in extremity
|
17.5%
7/40 • Number of events 7 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
5.0%
1/20 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
17.8%
8/45 • Number of events 8 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Dizziness
|
17.5%
7/40 • Number of events 7 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
15.0%
3/20 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
22.2%
10/45 • Number of events 10 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Headache
|
17.5%
7/40 • Number of events 7 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
13.3%
6/45 • Number of events 6 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Insomnia
|
10.0%
4/40 • Number of events 4 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
5.0%
1/20 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
15.6%
7/45 • Number of events 7 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.5%
9/40 • Number of events 9 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
15.0%
3/20 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
13.3%
6/45 • Number of events 6 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Dyspnoea
|
37.5%
15/40 • Number of events 15 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
10.0%
2/20 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
22.2%
10/45 • Number of events 10 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Epistaxis
|
15.0%
6/40 • Number of events 6 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
15.0%
3/20 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
11.1%
5/45 • Number of events 5 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Ecchymosis
|
10.0%
4/40 • Number of events 4 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
15.0%
3/20 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
2.2%
1/45 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Petechiae
|
10.0%
4/40 • Number of events 4 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
15.0%
3/20 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
15.6%
7/45 • Number of events 7 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Alopecia
|
17.5%
7/40 • Number of events 7 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
10.0%
2/20 • Number of events 2 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
22.2%
10/45 • Number of events 10 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
5/40 • Number of events 5 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
5.0%
1/20 • Number of events 1 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
15.6%
7/45 • Number of events 7 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
|
General disorders
Hypotension
|
10.0%
4/40 • Number of events 4 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
0.00%
0/20 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
6.7%
3/45 • Number of events 3 • Median length of follow-up was 143 weeks.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Arms D through I were terminated prematurely because of financial restrictions. Accordingly the company made the determination of the dosing schedule which was used in the subsequent Phase 3 study based on the results of Arms A through C.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place