Trial Outcomes & Findings for Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma (NCT NCT01950273)
NCT ID: NCT01950273
Last Updated: 2018-09-05
Results Overview
This outcome measure presents area under the concentration time curve of BI 695500 and Rituximab (MabThera®) over the first dosing interval (pre-infusion on Day 1 to pre-infusion on Day 8) (AUCDay 1-Day 8) for assessment of PK (Pharmacokinetics) similarity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
95 participants
Primary outcome timeframe
Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion 1, and at 24, 48, 72, 96 and 168 hours from start of infusion 1.
Results posted on
2018-09-05
Participant Flow
Participant milestones
| Measure |
BI 695500
The subjects received BI 695500 (Test)/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
|
Rituximab (MabThera®)
The subjects received Rituximab (MabThera® (Reference))/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
46
|
|
Overall Study
COMPLETED
|
45
|
46
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
BI 695500
The subjects received BI 695500 (Test)/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
|
Rituximab (MabThera®)
The subjects received Rituximab (MabThera® (Reference))/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Other not defined above
|
1
|
0
|
Baseline Characteristics
Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
BI 695500
n=49 Participants
The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
|
Rituximab (MabThera®)
n=46 Participants
The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 Years
STANDARD_DEVIATION 12.44 • n=5 Participants
|
58.4 Years
STANDARD_DEVIATION 11.48 • n=7 Participants
|
59.0 Years
STANDARD_DEVIATION 11.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion 1, and at 24, 48, 72, 96 and 168 hours from start of infusion 1.Population: The PK analysis Set Inferential (PKSI) used for inferential analysis of PK parameters, consisted of all randomized subjects who received at least one dose of trial medication and had an estimable primary PK parameter value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).
This outcome measure presents area under the concentration time curve of BI 695500 and Rituximab (MabThera®) over the first dosing interval (pre-infusion on Day 1 to pre-infusion on Day 8) (AUCDay 1-Day 8) for assessment of PK (Pharmacokinetics) similarity.
Outcome measures
| Measure |
BI 695500
n=46 Participants
The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
|
Rituximab (MabThera®)
n=43 Participants
The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
|
|---|---|---|
|
Area Under the Concentration (AUC) Time Curve of BI 695500 and Rituximab (MabThera®) Over the First Dosing Interval (Pre-infusion on Day 1 to Pre-infusion on Day 8)
|
15700 microgram*hour/millilitre (µg*h/mL)
Geometric Coefficient of Variation 69.8
|
17600 microgram*hour/millilitre (µg*h/mL)
Geometric Coefficient of Variation 27.9
|
SECONDARY outcome
Timeframe: Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion 4, and at 24, 48, 72, 96 and 168 hours from start of infusion 4.Population: The PK analysis Set Inferential (PKSI) used for inferential analysis of PK parameters, consisted of all randomized subjects who received at least one dose of trial medication and had estimable primary PK parameter value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).
This outcome measure presents area under the concentration of BI 695500 and Rituximab (MabThera®) over the fourth dosing interval (pre-infusion on Day 22 to Day 29).
Outcome measures
| Measure |
BI 695500
n=40 Participants
The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
|
Rituximab (MabThera®)
n=43 Participants
The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
|
|---|---|---|
|
AUC of BI 695500 and Rituximab (MabThera®) Over the Fourth Dosing Interval (Pre-infusion on Day 22 to Day 29) (AUC Day 22-Day 29)
|
41700 microgram*hour/millilitre (µg*h/mL)
Geometric Coefficient of Variation 32.3
|
44300 microgram*hour/millilitre (µg*h/mL)
Geometric Coefficient of Variation 24.8
|
SECONDARY outcome
Timeframe: Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion 1, and at 24, 48, 72, 96 and 168 hours from start of infusion 1.Population: The PK analysis Set Inferential (PKSI) used for inferential analysis of PK parameters, consisted of all randomized subjects who received at least one dose of trial medication and had estimable primary PK parameter value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).
This outcome measure presents maximum measured concentration of BI 695500 and Rituximab (MabThera®) in plasma (Cmax) following Dose 1
Outcome measures
| Measure |
BI 695500
n=46 Participants
The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
|
Rituximab (MabThera®)
n=44 Participants
The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
|
|---|---|---|
|
Maximum Measured Concentration of BI 695500 and Rituximab (MabThera®) in Plasma (Cmax) Following Dose 1
|
207.882 microgram/millilitre (µg/mL)
Geometric Coefficient of Variation 58.5
|
228.802 microgram/millilitre (µg/mL)
Geometric Coefficient of Variation 25.0
|
SECONDARY outcome
Timeframe: Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion 4, and at 24, 48, 72, 96, 168, 336, 672, 1344, 2016 and 2880 hours from start of infusion 4.Population: The PK analysis Set Inferential (PKSI) used for inferential analysis of PK parameters, consisted of all randomized subjects who received at least one dose of trial medication and had estimable primary PK parameter value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).
This outcome measure presents maximum measured concentration of Rituximab (MabThera®) and BI 695500 in plasma (Cmax) following Dose 4.
Outcome measures
| Measure |
BI 695500
n=39 Participants
The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
|
Rituximab (MabThera®)
n=42 Participants
The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
|
|---|---|---|
|
Maximum Measured Concentration of Rituximab (MabThera®) and BI 695500 in Plasma (Cmax) Following Dose 4
|
397.080 microgram/millilitre (µg/mL)
Geometric Coefficient of Variation 23.1
|
412.190 microgram/millilitre (µg/mL)
Geometric Coefficient of Variation 18.1
|
SECONDARY outcome
Timeframe: Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion, and at 24, 48, 72, 96 and 168 hours from start of infusion.Population: The PK analysis Set Descriptive (PKSD) consisted of all randomized subjects who received at least one dose of trial medication BI 695500 or Rituximab \[MabThera®\], had at least one post-treatment PK concentration value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).
This outcome measure presents area under the depletion-time curve of the CD19+ B-cell count (% change from baseline) in peripheral blood from pre-infusion on Day 1 until last measurement on Day 8 (pre-infusion) (AUC Day 1-Day 8, CD19+).
Outcome measures
| Measure |
BI 695500
n=32 Participants
The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
|
Rituximab (MabThera®)
n=41 Participants
The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
|
|---|---|---|
|
Area Under the Depletion-time Curve of the Cluster of Differentiation (CD)19+ B-cell Count (% Change From Baseline (CFB)) in Peripheral Blood From Pre-infusion on Day 1 Until Last Measurement on Day 8 (Pre-infusion)
|
-16895.2 Percentage CFB of CD19+ B-cells*hour
Standard Deviation 1016.9
|
-17064.4 Percentage CFB of CD19+ B-cells*hour
Standard Deviation 1403.2
|
SECONDARY outcome
Timeframe: Blood sampling was done at 168 hours from start of infusion.Population: The PK analysis Set Descriptive (PKSD) consisted of all randomized subjects who received at least one dose of trial medication BI 695500 or Rituximab \[MabThera®\], had at least one post-treatment PK concentration value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).
This outcome measure presents percent change from baseline of CD19+ B-cells in peripheral blood, measured after 7 days (i.e., Day 8 pre-infusion time point) (PCFBpre,2 CD19+).
Outcome measures
| Measure |
BI 695500
n=33 Participants
The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
|
Rituximab (MabThera®)
n=42 Participants
The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
|
|---|---|---|
|
Change From Baseline (%) of CD19+ B-cells in Peripheral Blood Measured After Seven Days on Day 8 (Day 8 Pre-infusion Time Point)
|
-99.2 Percentage (%) CFB of CD19+ B-cells
Standard Deviation 1.7
|
-98.8 Percentage (%) CFB of CD19+ B-cells
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: at Day 50.Population: Safety Analysis Set (SAS): The patients who received at least one dose of trial medication and classified as per treatment received.
Overall Response Rate (ORR) comprised Complete Response (CR) plus Partial Response (PR) evaluated approximately one month after last dose of BI 695500 or Rituximab \[MabThera®\]. Overall Response as defined by the revised International Working Group (IWG) Criteria 2007, using the Investigator's assessment.
Outcome measures
| Measure |
BI 695500
n=22 Participants
The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
|
Rituximab (MabThera®)
n=25 Participants
The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
|
|---|---|---|
|
Overall Response Rate (ORR) (Complete Response (CR) Plus Partial Response (PR)) Evaluated Approximately One Month After Last Dose of BI 695500 or Rituximab (MabThera®)
|
44.9 Percentage of subjects
|
54.3 Percentage of subjects
|
SECONDARY outcome
Timeframe: Adverse Events (AEs) that started or worsened on or after the first dose of study medication and prior to the last date of study medication + 4 months (120 days) inclusive.Population: Safety Analysis Set (SAS): The patients who received at least one dose of trial medication and classified as per treatment received.
This outcome measure presents percentage of patients with Treatment Emergent Adverse Events (TEAEs) selected for comparability assessment of BI 695500 and Rituximab (MabThera®).
Outcome measures
| Measure |
BI 695500
n=18 Participants
The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
|
Rituximab (MabThera®)
n=16 Participants
The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
|
|---|---|---|
|
Percentage of Patients With Treatment Emergent Adverse Events (TEAEs) Selected for Comparability Assessment of BI 695500 and Rituximab (MabThera®)
|
36.7 Percentage of patients
|
34.8 Percentage of patients
|
Adverse Events
BI 695500
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Rituximab (MabThera®)
Serious events: 3 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI 695500
n=49 participants at risk
The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
|
Rituximab (MabThera®)
n=46 participants at risk
The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
2.2%
1/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Endocrine disorders
Goitre
|
2.0%
1/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
0.00%
0/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Immune system disorders
Anaphylactoid reaction
|
2.0%
1/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
0.00%
0/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
0.00%
0/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
2.2%
1/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
2.2%
1/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
2.0%
1/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
0.00%
0/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
2.2%
1/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
Other adverse events
| Measure |
BI 695500
n=49 participants at risk
The subjects received BI 695500/100 mg/10 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by intravenous (IV) infusion.
|
Rituximab (MabThera®)
n=46 participants at risk
The subjects received Rituximab (MabThera®)/100 mg/10 mL and 500 mg/50 mL concentrate for solution for infusion at 375 mg/m2 once a week for 4 weeks (for a total of 4 dosages administered on Days 1, 8, 15, and 22) by IV infusion.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
6.5%
3/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
6.5%
3/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
3/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
6.5%
3/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.1%
3/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
0.00%
0/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Gastrointestinal disorders
Nausea
|
4.1%
2/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
15.2%
7/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
General disorders
Asthenia
|
12.2%
6/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
2.2%
1/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
General disorders
Fatigue
|
4.1%
2/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
8.7%
4/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
General disorders
Pyrexia
|
8.2%
4/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
10.9%
5/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Investigations
Alanine aminotransferase increased
|
10.2%
5/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
6.5%
3/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
3/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
6.5%
3/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
6.5%
3/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.1%
3/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
2.2%
1/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.1%
3/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
8.7%
4/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.2%
4/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
2.2%
1/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Nervous system disorders
Headache
|
10.2%
5/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
15.2%
7/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Psychiatric disorders
Insomnia
|
6.1%
3/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
2.2%
1/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.1%
2/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
6.5%
3/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
8.7%
4/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.1%
3/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
4.3%
2/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.1%
2/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
15.2%
7/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
|
Vascular disorders
Hypertension
|
0.00%
0/49 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
8.7%
4/46 • From first drug administration until 142 days after last drug administration, up to 156 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place