Trial Outcomes & Findings for Veliparib and Temozolomide in Treating Patients With Recurrent Glioblastoma (NCT NCT01026493)
NCT ID: NCT01026493
Last Updated: 2017-07-02
Results Overview
Dose limiting toxicity (DLT) = any of the following events within 1st 8 weeks of treatment attributable to study drugs: Any grade (gr) 3/4 thrombocytopenia, gr 4 anemia, gr 3 neutropenia with fever (\>100.4). gr 4 neutropenia lasting \> 7 days; Any non-hematologic (NH) gr 3+ toxicity (TOX), excluding alopecia, despite maximal medical therapy (MLT); NH TOX such as rash, nausea, vomiting, diarrhea, mucositis, hypophosphatemia, and hypertension will only be considered DLTs if they remain gr 3+ despite MLT; 2nd occurrence of thromboembolism; Failure to recover from TOX (\<= gr 1) to be eligible for re-treatment with study drugs \<= 14 days of last dose of either drug; Any episode of non-infectious radiologically observed pneumonitis gr 2-4 any duration. Dose level will be considered acceptable if \<= 1 of the 1st 6 eligible patients experiences a DLT. If current level is considered acceptable, dose escalation occurs. Otherwise preceding acceptable dose level will be declared the MTD.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
257 participants
Primary outcome timeframe
Start of treatment to 8 weeks.
Results posted on
2017-07-02
Participant Flow
Participant milestones
| Measure |
Phase I: Dose Level 1
ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2a
ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2b
ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase I: Dose Level 3
ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase II: Arm 1/BEV-NAIVE
ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
|
Phase II: Arm 2/BEV-NAIVE
ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
|
Phase II: Arm 1/BEV-FAILURE
ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase II: Arm 2/BEV-FAILURE
ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
9
|
8
|
75
|
76
|
36
|
38
|
|
Overall Study
COMPLETED
|
8
|
6
|
9
|
8
|
73
|
73
|
32
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
2
|
3
|
4
|
1
|
Reasons for withdrawal
| Measure |
Phase I: Dose Level 1
ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2a
ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2b
ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase I: Dose Level 3
ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase II: Arm 1/BEV-NAIVE
ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
|
Phase II: Arm 2/BEV-NAIVE
ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
|
Phase II: Arm 1/BEV-FAILURE
ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase II: Arm 2/BEV-FAILURE
ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
2
|
3
|
4
|
1
|
Baseline Characteristics
Veliparib and Temozolomide in Treating Patients With Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
Phase I: Dose Level 1
n=8 Participants
ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2a
n=6 Participants
ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2b
n=9 Participants
ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase I: Dose Level 3
n=8 Participants
ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase II: Arm 1/BEV-NAIVE
n=73 Participants
ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
|
Phase II: Arm 2/BEV-NAIVE
n=73 Participants
ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
|
Phase II: Arm 1/BEV-FAILURE
n=32 Participants
ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase II: Arm 2/BEV-FAILURE
n=37 Participants
ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48 years
n=5 Participants
|
51 years
n=7 Participants
|
53 years
n=5 Participants
|
41 years
n=4 Participants
|
56 years
n=21 Participants
|
56 years
n=10 Participants
|
56 years
n=115 Participants
|
57 years
n=24 Participants
|
56 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
14 Participants
n=24 Participants
|
84 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
47 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
23 Participants
n=24 Participants
|
162 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Start of treatment to 8 weeks.Population: Eligible patients who started study treatment
Dose limiting toxicity (DLT) = any of the following events within 1st 8 weeks of treatment attributable to study drugs: Any grade (gr) 3/4 thrombocytopenia, gr 4 anemia, gr 3 neutropenia with fever (\>100.4). gr 4 neutropenia lasting \> 7 days; Any non-hematologic (NH) gr 3+ toxicity (TOX), excluding alopecia, despite maximal medical therapy (MLT); NH TOX such as rash, nausea, vomiting, diarrhea, mucositis, hypophosphatemia, and hypertension will only be considered DLTs if they remain gr 3+ despite MLT; 2nd occurrence of thromboembolism; Failure to recover from TOX (\<= gr 1) to be eligible for re-treatment with study drugs \<= 14 days of last dose of either drug; Any episode of non-infectious radiologically observed pneumonitis gr 2-4 any duration. Dose level will be considered acceptable if \<= 1 of the 1st 6 eligible patients experiences a DLT. If current level is considered acceptable, dose escalation occurs. Otherwise preceding acceptable dose level will be declared the MTD.
Outcome measures
| Measure |
Phase I: Dose Level 1
n=8 Participants
ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2a
n=6 Participants
ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2b
n=9 Participants
ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase I: Dose Level 3
n=8 Participants
ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
|
|---|---|---|---|---|
|
Phase 1: Maximum Tolerated Dose (MTD)
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Randomization to 6 months.Population: Randomized patients with measurable disease after surgery, at least one cycle of treatment, evaluable for 6 month PFS, and within the required sample size (i.e. the first 53 BEV-naive patients and the first 26 BEV-failure patients- the number of patients will be less than sample size if not enough patients meet the criteria).
For patients with measureable disease after surgery: Progression defined as ≥ 25% increase in size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable/increased. Bevacizumab (BEV)-naïve group: p0= 15% as estimate of 6-mo. PFS \[null hypothesis (NH)\], p1= 30%, with a 15% absolute increase \[alternative hypothesis (AH)\]. Error rates of 10% alpha and 10% beta. If \<= 11 patients experience 6-month PFS of the first 53 analyzable patients, then do not reject the null hypothesis that the 6-month PFS rate of experimental arm is less than 15%; BEV-failure group: p0 = 2% as a conservative estimate of 6-month PFS \[NH\], p1 = 15%, with a 13% absolute increase \[AH\]. Using first 26 analyzable subjects for each experimental arm, there is \>= 90% power to detect \>= 15% increase at a significance level of 0.10, using a 1-sided binomial test. If \>= 2 patients (8%) are progression free at 6 mo., then claim this regimen to be promising in the patient group.
Outcome measures
| Measure |
Phase I: Dose Level 1
n=53 Participants
ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2a
n=53 Participants
ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2b
n=19 Participants
ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase I: Dose Level 3
n=26 Participants
ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
|
|---|---|---|---|---|
|
Phase II: 6-month Progression-free Survival (PFS) Rate for Patients With Measurable Disease After Surgery
|
9 participants
|
9 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Analysis occurs after all patients have been on study for at 6 months. (Patients are followed from randomization to death or study termination whichever occurs first.)Population: Eligible patients with at least one cycle of treatment
Response and progression will be evaluated using standard criteria for patients with malignant gliomas (Macdonald 1990). Partial response and complete response are centrally reviewed.
Outcome measures
| Measure |
Phase I: Dose Level 1
n=53 Participants
ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2a
n=53 Participants
ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2b
n=19 Participants
ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase I: Dose Level 3
n=26 Participants
ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
|
|---|---|---|---|---|
|
Phase II: Objective Response (Partial and Complete Response) Rate for Patients With Measurable Disease After Surgery
|
0 percentage of participants
Interval 0.0 to 0.0
|
3.8 percentage of participants
Interval 0.0 to 8.9
|
5.3 percentage of participants
Interval 0.0 to 15.3
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Analysis occurs after all patients have been on study for at 6 months. (Patients are followed from randomization to death or study termination whichever occurs first.)Population: Eligible patients
Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 6 months.
Outcome measures
| Measure |
Phase I: Dose Level 1
n=73 Participants
ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2a
n=73 Participants
ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2b
n=32 Participants
ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase I: Dose Level 3
n=37 Participants
ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
|
|---|---|---|---|---|
|
Phase II: Overall Survival (OS)
|
10.3 months
Interval 7.6 to 13.4
|
10.7 months
Interval 7.6 to 12.6
|
4.7 months
Interval 3.0 to 6.3
|
4.7 months
Interval 3.4 to 7.0
|
Adverse Events
Phase I: Dose Level 1
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase I: Dose Level 2a
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase I: Dose Level 2b
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase I: Dose Level 3
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II: Arm 1/BEV-NAIVE
Serious events: 19 serious events
Other events: 70 other events
Deaths: 0 deaths
Phase II: Arm 2/BEV-NAIVE
Serious events: 15 serious events
Other events: 70 other events
Deaths: 0 deaths
Phase II: Arm 1/BEV-FAILURE
Serious events: 14 serious events
Other events: 31 other events
Deaths: 0 deaths
Phase II: Arm 2/BEV-FAILURE
Serious events: 10 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: Dose Level 1
n=8 participants at risk
ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2a
n=6 participants at risk
ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2b
n=9 participants at risk
ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase I: Dose Level 3
n=8 participants at risk
ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase II: Arm 1/BEV-NAIVE
n=73 participants at risk
ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
|
Phase II: Arm 2/BEV-NAIVE
n=73 participants at risk
ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
|
Phase II: Arm 1/BEV-FAILURE
n=32 participants at risk
ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase II: Arm 2/BEV-FAILURE
n=37 participants at risk
ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.1%
1/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.1%
1/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.1%
1/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Death NOS
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.1%
1/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.7%
1/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Lung infection
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Meningitis
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Sepsis
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.1%
1/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Skin infection
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.1%
1/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Wound infection
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.4%
2/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Creatinine increased
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.1%
1/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.8%
5/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.1%
1/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.1%
3/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.6%
5/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
White blood cell decreased
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.1%
3/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.2%
2/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.2%
2/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.1%
1/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.4%
2/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.2%
2/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.1%
3/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
18.8%
6/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.8%
4/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.1%
1/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.8%
5/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.1%
3/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Intracranial hemorrhage
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
2/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Seizure
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.7%
1/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.8%
5/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.5%
4/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Stroke
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Syncope
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
2/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.1%
3/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.2%
2/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Other adverse events
| Measure |
Phase I: Dose Level 1
n=8 participants at risk
ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2a
n=6 participants at risk
ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
|
Phase I: Dose Level 2b
n=9 participants at risk
ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase I: Dose Level 3
n=8 participants at risk
ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase II: Arm 1/BEV-NAIVE
n=73 participants at risk
ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
|
Phase II: Arm 2/BEV-NAIVE
n=73 participants at risk
ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
|
Phase II: Arm 1/BEV-FAILURE
n=32 participants at risk
ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
|
Phase II: Arm 2/BEV-FAILURE
n=37 participants at risk
ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Vitreous hemorrhage
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Lethargy
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Memory impairment
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.7%
1/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.8%
5/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.4%
12/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.4%
3/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.1%
3/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
2/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
37.5%
3/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
32.9%
24/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
34.2%
25/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
8/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
29.7%
11/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
27.4%
20/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.4%
12/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
34.4%
11/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.2%
6/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
2/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.1%
3/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.1%
1/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.7%
1/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
2/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
26.0%
19/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
31.5%
23/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
8/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.1%
3/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Edema limbs
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.7%
1/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.5%
4/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.1%
1/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
2/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
55.6%
5/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
50.0%
4/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
49.3%
36/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
49.3%
36/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
50.0%
16/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
48.6%
18/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
2/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.5%
4/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
3/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
50.0%
4/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
13.7%
10/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.9%
16/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
18.8%
6/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.1%
3/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.7%
1/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
66.7%
6/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
37.5%
3/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
42.5%
31/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
42.5%
31/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
37.5%
12/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
35.1%
13/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count decreased
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
34.2%
25/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.5%
15/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.9%
7/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.1%
3/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.7%
1/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
66.7%
6/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
37.5%
3/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
53.4%
39/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
65.8%
48/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
50.0%
16/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
59.5%
22/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
White blood cell decreased
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.7%
1/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
62.5%
5/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
43.8%
32/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
38.4%
28/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
34.4%
11/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
27.0%
10/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
2/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
37.5%
3/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
23.3%
17/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
24.7%
18/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.1%
9/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
27.0%
10/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.5%
4/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.6%
7/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.4%
3/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.8%
4/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.5%
4/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.1%
3/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
4/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.1%
3/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
2/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
2/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.6%
5/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.1%
3/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Cognitive disturbance
|
25.0%
2/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.2%
6/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.8%
5/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.2%
2/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.4%
2/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysarthria
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.8%
5/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.5%
4/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.2%
2/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.1%
3/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
25.0%
2/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.7%
1/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
55.6%
5/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
38.4%
28/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
35.6%
26/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
31.2%
10/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.6%
8/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Hypersomnia
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
2/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.2%
2/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Seizure
|
25.0%
2/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.7%
1/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.2%
14/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
13.7%
10/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
4/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.8%
4/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Tremor
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
2/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.6%
7/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.4%
3/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.7%
1/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.5%
4/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.8%
5/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.4%
3/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.1%
3/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
2/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
2/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.2%
2/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.4%
2/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary tract pain
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.2%
6/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.1%
1/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
2/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
2/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.2%
2/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
12.5%
1/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/6
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.4%
1/73
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/32
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.7%
1/37
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER