Trial Outcomes & Findings for This Study Tests Different Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF). The Study Tests How BI 1015550 is Taken up by the Body and How Well it is Tolerated. (NCT NCT03422068)
NCT ID: NCT03422068
Last Updated: 2025-11-28
Results Overview
The analysis of AEs was based on the concept of treatment-emergent AEs (TEAEs). All AEs which occurred through the treatment phase and throughout the residual effect period (REP) were considered as on treatment. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment at 12 Feb 2019 or 12 weeks for those entered before approval.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Results posted on
2025-11-28
Participant Flow
This randomized, double-blind, placebo-controlled, multiple rising dose trial was to test safety and tolerability of BI 1015550 in patients with idiopathic pulmonary fibrosis under dosage of 18mg and 24mg twice daily (bid). Dose escalation was stopped after the 18 mg bid dose group as predefined stopping criteria was met.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. Participant flow was based on treatment period.
Participant milestones
| Measure |
Placebo
3 tablets of Placebo, matching in size and weight to BI 1015550 6 milligram (mg) tablet, were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
18 mg BI 1015550
3 tablets of 6 milligram (mg) of BI 101550 (total: 18 mg) were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily (bid). Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
10
|
|
Overall Study
COMPLETED
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
3 tablets of Placebo, matching in size and weight to BI 1015550 6 milligram (mg) tablet, were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
18 mg BI 1015550
3 tablets of 6 milligram (mg) of BI 101550 (total: 18 mg) were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily (bid). Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Inconvenience to frequent study visits
|
0
|
1
|
Baseline Characteristics
This Study Tests Different Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF). The Study Tests How BI 1015550 is Taken up by the Body and How Well it is Tolerated.
Baseline characteristics by cohort
| Measure |
Placebo
n=5 Participants
3 tablets of Placebo, matching in size and weight to BI 1015550 6 milligram (mg) tablet, were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
18 mg BI 1015550
n=10 Participants
3 tablets of 6 milligram (mg) of BI 101550 (total: 18 mg) were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily (bid). Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.2 Years
STANDARD_DEVIATION 3.3 • n=9 Participants
|
69.5 Years
STANDARD_DEVIATION 10.1 • n=6 Participants
|
69.7 Years
STANDARD_DEVIATION 8.3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
13 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.Population: Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
The analysis of AEs was based on the concept of treatment-emergent AEs (TEAEs). All AEs which occurred through the treatment phase and throughout the residual effect period (REP) were considered as on treatment. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment at 12 Feb 2019 or 12 weeks for those entered before approval.
Outcome measures
| Measure |
18 mg BI 1015550
n=10 Participants
3 tablets of 6 milligram (mg) of BI 101550 (total: 18 mg) were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily (bid). Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
Placebo
n=5 Participants
3 tablets of Placebo, matching in size and weight to BI 1015550 6 milligram (mg) tablet, were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
|---|---|---|
|
Percentage of Participants With Drug-related Adverse Events (AEs) On-treatment
|
90.0 Percentage of participants
|
60.0 Percentage of participants
|
SECONDARY outcome
Timeframe: On Day 1, within 2 hours before morning dose and at 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after morning dose.Population: Pharmacokinetic parameter set (PKS): This patient set included all patients in the TS who provided at least one pharmacokinetic (PK) parameter that was not excluded because of protocol deviations relevant to the analysis of PK endpoints.
Area under the concentration-time curve (AUCτ,1) of the BI 1015550 in plasma over a uniform dosing interval τ after administration of the first dose on Day 1.
Outcome measures
| Measure |
18 mg BI 1015550
n=10 Participants
3 tablets of 6 milligram (mg) of BI 101550 (total: 18 mg) were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily (bid). Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
Placebo
3 tablets of Placebo, matching in size and weight to BI 1015550 6 milligram (mg) tablet, were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
|---|---|---|
|
Area Under the Concentration-time Curve (AUCτ,1) of the BI 1015550 in Plasma Over a Uniform Dosing Interval τ After Administration of the First Dose on Day 1
|
1990 nanomol (nmol) * hours (h) / Litre (L)
Geometric Coefficient of Variation 18.2
|
—
|
SECONDARY outcome
Timeframe: On Day 1, within 2 hours before morning dose and at 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after morning dose.Population: Pharmacokinetic parameter set (PKS): This patient set included all patients in the TS who provided at least one pharmacokinetic (PK) parameter that was not excluded because of protocol deviations relevant to the analysis of PK endpoints.
Maximum measured concentration (Cmax) of the BI 1015550 in plasma on Day 1.
Outcome measures
| Measure |
18 mg BI 1015550
n=10 Participants
3 tablets of 6 milligram (mg) of BI 101550 (total: 18 mg) were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily (bid). Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
Placebo
3 tablets of Placebo, matching in size and weight to BI 1015550 6 milligram (mg) tablet, were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
|---|---|---|
|
Maximum Measured Concentration (Cmax) of the BI 1015550 in Plasma on Day 1
|
277 nanomol (nmol) / Litre (L)
Geometric Coefficient of Variation 23.1
|
—
|
SECONDARY outcome
Timeframe: On Day 14, within 2 hours before morning dose and at 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after morning dose.Population: Pharmacokinetic parameter set (PKS): This patient set included all patients in the TS who provided at least one pharmacokinetic (PK) parameter that was not excluded because of protocol deviations relevant to the analysis of PK endpoints.
Area under the concentration-time curve (AUCτ,ss) of the BI 1015550 in plasma at steady state over a uniform dosing interval τ on Day 14.
Outcome measures
| Measure |
18 mg BI 1015550
n=10 Participants
3 tablets of 6 milligram (mg) of BI 101550 (total: 18 mg) were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily (bid). Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
Placebo
3 tablets of Placebo, matching in size and weight to BI 1015550 6 milligram (mg) tablet, were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
|---|---|---|
|
Area Under the Concentration-time Curve (AUCτ,ss) of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval τ on Day 14
|
3720 nanomol (nmol) * hours (h) / Litre (L)
Geometric Coefficient of Variation 49.5
|
—
|
SECONDARY outcome
Timeframe: On Day 14, within 2 hours before morning dose and at 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after morning dose.Population: Pharmacokinetic parameter set (PKS): This patient set included all patients in the TS who provided at least one pharmacokinetic (PK) parameter that was not excluded because of protocol deviations relevant to the analysis of PK endpoints.
Maximum measured concentration (Cmax,ss) of the BI 1015550 in plasma at steady state over a uniform dosing interval τ on Day 14.
Outcome measures
| Measure |
18 mg BI 1015550
n=10 Participants
3 tablets of 6 milligram (mg) of BI 101550 (total: 18 mg) were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily (bid). Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
Placebo
3 tablets of Placebo, matching in size and weight to BI 1015550 6 milligram (mg) tablet, were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
|---|---|---|
|
Maximum Measured Concentration (Cmax,ss) of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval τ on Day 14
|
460 nanomol (nmol) / Litre (L)
Geometric Coefficient of Variation 41.7
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
18 mg BI 1015550
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=5 participants at risk
3 tablets of Placebo, matching in size and weight to BI 1015550 6 milligram (mg) tablet, were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
18 mg BI 1015550
n=10 participants at risk
3 tablets of 6 milligram (mg) of BI 101550 (total: 18 mg) were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily (bid). Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
|---|---|---|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
Other adverse events
| Measure |
Placebo
n=5 participants at risk
3 tablets of Placebo, matching in size and weight to BI 1015550 6 milligram (mg) tablet, were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
18 mg BI 1015550
n=10 participants at risk
3 tablets of 6 milligram (mg) of BI 101550 (total: 18 mg) were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily (bid). Treatment period was 4 weeks for patients entered after approval of a global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Eye disorders
Vision blurred
|
20.0%
1/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
0.00%
0/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
2/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
40.0%
4/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
30.0%
3/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
General disorders
Fatigue
|
20.0%
1/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
20.0%
2/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
General disorders
General physical health deterioration
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
40.0%
4/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Infections and infestations
Pharyngitis
|
20.0%
1/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
0.00%
0/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Infections and infestations
Respiratory tract infection
|
20.0%
1/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
0.00%
0/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Investigations
General physical condition decreased
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Investigations
Occult blood positive
|
20.0%
1/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
30.0%
3/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
20.0%
2/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
20.0%
2/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
20.0%
2/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
20.0%
2/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
20.0%
1/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
0.00%
0/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
10.0%
1/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
20.0%
1/5 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
0.00%
0/10 • From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Treatment period was 4 weeks for patients entered after approval of the global protocol amendment 3 at 12 Feb 2019 or 12 weeks for those entered before approval. Treated set (TS): This patient set included all patients who received at least one dose of study drug. It was used for the analysis of safety, demographic data, and baseline characteristics.
|
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 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