Trial Outcomes & Findings for BI 6727 (Volasertib) Monotherapy Phase I Trial in Japanese Patients With Advanced Solid Tumours (NCT NCT01348347)
NCT ID: NCT01348347
Last Updated: 2018-08-06
Results Overview
The following drug-related adverse events (AE) were defined as DLT; 1. Haematological toxicities: CTCAE(Common Terminology Criteria for Adverse Events) grade 4 neutropenia persisted for 7 or more days, CTCAE grade 4 thrombocytopenia or CTCAE grade 3 thrombocytopenia requiring blood transfusion. 2. Non-haematological toxicities: CTCAE grade ≥3 non-haematological toxicities. The following toxicity with neutropenia was defined as DLT.- CTCAE grade 3 febrile neutropenia persisted for over 2 days, Clinically significant laboratory abnormalities of CTCAE grade ≥3 persisted for over 3 days. The following laboratory abnormalities should be defined as DLT. - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): \>5.0 × ULN persisted for 7 days or longer - Creatinine: \>3.0 × upper limit of normal(ULN) (if the creatinine abnormality was observed even once) - Persistent electrolyte abnormality assessed by the investigator.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
21 days
Results posted on
2018-08-06
Participant Flow
15 patients were treated and analysed.
This was an open-label, uncontrolled, dose escalation phase I study of once every three weeks intravenous treatment with BI 6727(volasertib) in Japanese patients with advanced solid tumours.
Participant milestones
| Measure |
Volasertib 200 mg Cohort
Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 300 mg Cohort
Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 350 mg Cohort
Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
6
|
Reasons for withdrawal
| Measure |
Volasertib 200 mg Cohort
Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 300 mg Cohort
Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 350 mg Cohort
Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
|
Overall Study
Progressive disease
|
2
|
5
|
5
|
Baseline Characteristics
BI 6727 (Volasertib) Monotherapy Phase I Trial in Japanese Patients With Advanced Solid Tumours
Baseline characteristics by cohort
| Measure |
Volasertib 200 mg Cohort
n=3 Participants
Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 300 mg Cohort
n=6 Participants
Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 350 mg Cohort
n=6 Participants
Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.0 Years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
58.8 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
60.8 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
61.7 Years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.
The following drug-related adverse events (AE) were defined as DLT; 1. Haematological toxicities: CTCAE(Common Terminology Criteria for Adverse Events) grade 4 neutropenia persisted for 7 or more days, CTCAE grade 4 thrombocytopenia or CTCAE grade 3 thrombocytopenia requiring blood transfusion. 2. Non-haematological toxicities: CTCAE grade ≥3 non-haematological toxicities. The following toxicity with neutropenia was defined as DLT.- CTCAE grade 3 febrile neutropenia persisted for over 2 days, Clinically significant laboratory abnormalities of CTCAE grade ≥3 persisted for over 3 days. The following laboratory abnormalities should be defined as DLT. - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): \>5.0 × ULN persisted for 7 days or longer - Creatinine: \>3.0 × upper limit of normal(ULN) (if the creatinine abnormality was observed even once) - Persistent electrolyte abnormality assessed by the investigator.
Outcome measures
| Measure |
Volasertib 200 mg Cohort
n=3 Participants
Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 300 mg Cohort
n=6 Participants
Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 350 mg Cohort
n=6 Participants
Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD).
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.
Maximum tolerated dose (MTD) of volasertib was the highest dose tested at which DLT was developed in not more than 1 of 6 patients in the course 1.
Outcome measures
| Measure |
Volasertib 200 mg Cohort
n=15 Participants
Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 300 mg Cohort
Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 350 mg Cohort
Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Volasertib
|
300 mg
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1: Unconfirmed objective response. The patients with complete response (CR) or partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Volasertib 200 mg Cohort
n=3 Participants
Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 300 mg Cohort
n=6 Participants
Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 350 mg Cohort
n=6 Participants
Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
|---|---|---|---|
|
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
No
|
3 Participants
|
6 Participants
|
5 Participants
|
|
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Yes
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.
Disease control rate according to RECIST v1.1 - Unconfirmed disease control. The patients with complete response (CR), partial response (PR) or stable disease (SD).
Outcome measures
| Measure |
Volasertib 200 mg Cohort
n=3 Participants
Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 300 mg Cohort
n=6 Participants
Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 350 mg Cohort
n=6 Participants
Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
|---|---|---|---|
|
Disease Control Rate According to RECIST v1.1
No
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Disease Control Rate According to RECIST v1.1
Yes
|
3 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Pharmacokinetic (PK) plasma samples were taken at: 5 minutes predose, 1hour, 2hours (h), 3h, 4h, 8h, 24h, 48h, 72h, 96h, 168h and 336h of course1.Population: The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.
Maximum concentration of an analyte in plasma
Outcome measures
| Measure |
Volasertib 200 mg Cohort
n=3 Participants
Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 300 mg Cohort
n=6 Participants
Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 350 mg Cohort
n=6 Participants
Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
|---|---|---|---|
|
Cmax of Volasertib (BI 6727)
|
398 ng/mL
Geometric Coefficient of Variation 17.6
|
501 ng/mL
Geometric Coefficient of Variation 17.7
|
615 ng/mL
Geometric Coefficient of Variation 37.7
|
SECONDARY outcome
Timeframe: PK plasma samples were taken at: 5 minutes predose, 1hour, 2hours (h), 3h, 4h, 8h, 24h, 48h, 72h, 96h, 168h and 336h of course1.Population: The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) of Volasertib (BI 6727).
Outcome measures
| Measure |
Volasertib 200 mg Cohort
n=3 Participants
Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 300 mg Cohort
n=6 Participants
Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 350 mg Cohort
n=6 Participants
Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) of Volasertib (BI 6727)
|
4350 ng*h/mL
Geometric Coefficient of Variation 25.0
|
5300 ng*h/mL
Geometric Coefficient of Variation 16.3
|
7260 ng*h/mL
Geometric Coefficient of Variation 14.9
|
SECONDARY outcome
Timeframe: PK plasma samples were taken at: 5 minutes predose, 1hour, 2hours (h), 3h, 4h, 8h, 24h, 48h, 72h, 96h, 168h and 336h of course1.Population: The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point (AUC0-tz) of Volasertib (BI 6727).
Outcome measures
| Measure |
Volasertib 200 mg Cohort
n=3 Participants
Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 300 mg Cohort
n=6 Participants
Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 350 mg Cohort
n=6 Participants
Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz) of Volasertib (BI 6727)
|
4000 ng*h/mL
Geometric Coefficient of Variation 19.1
|
5100 ng*h/mL
Geometric Coefficient of Variation 16.6
|
6900 ng*h/mL
Geometric Coefficient of Variation 15.5
|
Adverse Events
Volasertib 200 mg Cohort
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Volasertib 300 mg Cohort
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Volasertib 350 mg Cohort
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Volasertib 200 mg Cohort
n=3 participants at risk
Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 300 mg Cohort
n=6 participants at risk
Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 350 mg Cohort
n=6 participants at risk
Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
Other adverse events
| Measure |
Volasertib 200 mg Cohort
n=3 participants at risk
Volasertib 200 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 300 mg Cohort
n=6 participants at risk
Volasertib 300 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
Volasertib 350 mg Cohort
n=6 participants at risk
Volasertib 350 mg was infused intravenously (over 2 hours) on Day 1 in a 3-week treatment course.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Blood and lymphatic system disorders
Leukopenia
|
66.7%
2/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
83.3%
5/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
100.0%
6/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
66.7%
4/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
100.0%
6/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
66.7%
2/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
100.0%
6/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
100.0%
6/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
50.0%
3/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
General disorders
Fatigue
|
33.3%
1/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
33.3%
2/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
66.7%
4/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
General disorders
Injection site reaction
|
33.3%
1/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Infections and infestations
Cystitis
|
33.3%
1/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
1/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
50.0%
3/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
50.0%
3/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
33.3%
2/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Investigations
Electrocardiogram QT prolonged
|
33.3%
1/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
33.3%
2/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
66.7%
4/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
33.3%
2/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
33.3%
2/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
33.3%
1/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
33.3%
2/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
33.3%
1/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
0.00%
0/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
16.7%
1/6 • From the day of informed consent(-14 days) until the follow-up visit, 72 days.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER