Trial Outcomes & Findings for Atrasentan Spermatogenesis and Testicular Function (NCT NCT02118714)
NCT ID: NCT02118714
Last Updated: 2019-05-07
Results Overview
Percentage of Subjects with a Sperm Concentration \< 15 million per mL by Treatment Week 26. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Up to 26 weeks
Results posted on
2019-05-07
Participant Flow
The Safety Analysis Set included all enrolled participants who received \>= 1 dose of Atrasentan (N = 20); of these 20, 6 participants entered an Observational Period of up to an additional 52 weeks.
Participant milestones
| Measure |
Atrasentan
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Atrasentan
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Atrasentan Spermatogenesis and Testicular Function
Baseline characteristics by cohort
| Measure |
Atrasentan
n=20 Participants
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: Evaluable Set: Subjects who met 1 of the following: Study drug compliance ≥ 70%, completed Treatment Period, all planned sperm samples collected; or 2) at least 1 dose study drug, a sperm concentration value that was \<15 million/mL observed by the end of the Treatment Period or had a ≥50% reduction from Baseline at the end of the Treatment Period.
Percentage of Subjects with a Sperm Concentration \< 15 million per mL by Treatment Week 26. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period.
Outcome measures
| Measure |
Atrasentan
n=17 Participants
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26
|
23.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 52 weeks after the Treatment PeriodPopulation: Evaluable Set
The percentage of participants who entered the Observational Period and did not return to within 15% of Baseline sperm concentration or above during the 52-week Observational Period. Duplicate semen samples were to be collected during the Observational Period. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period.
Outcome measures
| Measure |
Atrasentan
n=17 Participants
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Percentage of Participants Who Entered the Observation Period and Did Not Return to Within 15% of Baseline Sperm Concentration or Above During the 52-Week Observational Period
|
11.8 percentage of participants
|
SECONDARY outcome
Timeframe: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
Duplicate semen samples will be collected during the Treatment and Observational Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in sperm concentration.
Outcome measures
| Measure |
Atrasentan
n=18 Participants
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration
Treatment Period Week 13
|
2.2 sperm * million per milliliter(X10^6/mL)
Standard Deviation 42.21
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration
Treatment Period Week 26
|
-10.6 sperm * million per milliliter(X10^6/mL)
Standard Deviation 53.44
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration
Observation Period Week 13
|
35.8 sperm * million per milliliter(X10^6/mL)
Standard Deviation 113.60
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration
Observation Period Week 26
|
-16.5 sperm * million per milliliter(X10^6/mL)
Standard Deviation 0.00
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration
Observation Period Week 39
|
-27.5 sperm * million per milliliter(X10^6/mL)
Standard Deviation 19.09
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration
Observation Period Week 52
|
-25.8 sperm * million per milliliter(X10^6/mL)
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a lower sperm motility (worsening).
Outcome measures
| Measure |
Atrasentan
n=18 Participants
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility
Observation Period Week 26
|
-6.3 percent motility
Standard Deviation 5.30
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility
Observation Period Week 39
|
10.8 percent motility
Standard Deviation 15.20
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility
Treatment Period Week 13
|
-5.8 percent motility
Standard Deviation 13.65
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility
Treatment Period Week 26
|
-7.4 percent motility
Standard Deviation 15.77
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility
Observation Period Week 13
|
-0.3 percent motility
Standard Deviation 19.20
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility
Observation Period Week 52
|
1.8 percent motility
Standard Deviation 16.62
|
SECONDARY outcome
Timeframe: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
Duplicate semen samples will be collected during the Treatment and Observational Periods. The percentage of sperm with normal versus abnormal morphology will be determined via microscopic analysis. A positive change from baseline indicates an improved sperm morphology.
Outcome measures
| Measure |
Atrasentan
n=18 Participants
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology
Treatment Period Week 13
|
-1.1 percentage of normal
Standard Deviation 4.78
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology
Treatment Period Week 26
|
-2.2 percentage of normal
Standard Deviation 7.54
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology
Observation Period Week 13
|
-0.8 percentage of normal
Standard Deviation 7.53
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology
Observation Period Week 26
|
-6.8 percentage of normal
Standard Deviation 0.35
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology
Observation Period Week 39
|
-2.3 percentage of normal
Standard Deviation 1.77
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology
Observation Period Week 52
|
1.8 percentage of normal
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in semen volume.
Outcome measures
| Measure |
Atrasentan
n=18 Participants
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume
Treatment Period Week 13
|
0.0 milliliter (mL)
Standard Deviation 0.65
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume
Treatment Period Week 26
|
-0.3 milliliter (mL)
Standard Deviation 0.75
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume
Observation Period Week 13
|
0.0 milliliter (mL)
Standard Deviation 1.39
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume
Observation Period Week 26
|
0.0 milliliter (mL)
Standard Deviation 0.35
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume
Observation Period Week 39
|
0.1 milliliter (mL)
Standard Deviation 0.42
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume
Observation Period Week 52
|
-0.4 milliliter (mL)
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum testosterone.
Outcome measures
| Measure |
Atrasentan
n=18 Participants
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone
Treatment Period Week 13
|
0.2 nanomole/liter (nmol/L)
Standard Deviation 2.18
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone
Treatment Period Week 26
|
0.8 nanomole/liter (nmol/L)
Standard Deviation 2.33
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone
Observation Period Week 13
|
0.6 nanomole/liter (nmol/L)
Standard Deviation 2.08
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone
Observation Period Week 26
|
-0.3 nanomole/liter (nmol/L)
Standard Deviation 0.85
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone
Observation Period Week 39
|
-1.6 nanomole/liter (nmol/L)
Standard Deviation 1.37
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone
Observation Period Week 52
|
-1.1 nanomole/liter (nmol/L)
Standard Deviation 1.68
|
SECONDARY outcome
Timeframe: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
Serum hormones levels were tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum estradiol.
Outcome measures
| Measure |
Atrasentan
n=18 Participants
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol
Treatment Period Week 13
|
-11.7 Picomoles Per Litre (pmol/L)
Standard Deviation 44.57
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol
Treatment Period Week 26
|
-18.6 Picomoles Per Litre (pmol/L)
Standard Deviation 42.04
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol
Observation Period Week 13
|
-17.8 Picomoles Per Litre (pmol/L)
Standard Deviation 62.78
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol
Observation Period Week 26
|
-47.3 Picomoles Per Litre (pmol/L)
Standard Deviation 39.97
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol
Observation Period Week 39
|
20.3 Picomoles Per Litre (pmol/L)
Standard Deviation 4.78
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol
Observation Period Week 52
|
10.5 Picomoles Per Litre (pmol/L)
Standard Deviation 45.54
|
SECONDARY outcome
Timeframe: From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum lutenizing hormone.
Outcome measures
| Measure |
Atrasentan
n=18 Participants
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH)
Treatment Period Week 13
|
1.0 International Units/Liter (IU/L)
Standard Deviation 2.60
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH)
Treatment Period Week 26
|
0.7 International Units/Liter (IU/L)
Standard Deviation 2.44
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH)
Observation Period Week 13
|
1.3 International Units/Liter (IU/L)
Standard Deviation 1.33
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH)
Observation Period Week 26
|
1.9 International Units/Liter (IU/L)
Standard Deviation 2.35
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH)
Observation Period Week 39
|
0.5 International Units/Liter (IU/L)
Standard Deviation 0.07
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH)
Observation Period Week 52
|
1.8 International Units/Liter (IU/L)
Standard Deviation 3.46
|
SECONDARY outcome
Timeframe: From Week 0 to Treatment Week 26 and Observation Week 52Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum follicle stimulating hormone.
Outcome measures
| Measure |
Atrasentan
n=18 Participants
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH)
Treatment Period Week 13
|
1.1 International Units/Liter (IU/L)
Standard Deviation 2.43
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH)
Treatment Period Week 26
|
0.8 International Units/Liter (IU/L)
Standard Deviation 1.91
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH)
Observation Period Week 13
|
0.4 International Units/Liter (IU/L)
Standard Deviation 1.60
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH)
Observation Period Week 26
|
0.7 International Units/Liter (IU/L)
Standard Deviation 1.49
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH)
Observation Period Week 39
|
0.4 International Units/Liter (IU/L)
Standard Deviation 1.57
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH)
Observation Period Week 52
|
0.8 International Units/Liter (IU/L)
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum Inhibin B.
Outcome measures
| Measure |
Atrasentan
n=18 Participants
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B
Observation Period Week 26
|
-22.7 picogram per milliliter (pg/mL)
Standard Deviation 27.10
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B
Observation Period Week 39
|
-21.0 picogram per milliliter (pg/mL)
Standard Deviation 16.97
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B
Observation Period Week 52
|
-5.5 picogram per milliliter (pg/mL)
Standard Deviation 2.12
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B
Treatment Period Week 13
|
-2.7 picogram per milliliter (pg/mL)
Standard Deviation 24.19
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B
Treatment Period Week 26
|
-8.8 picogram per milliliter (pg/mL)
Standard Deviation 34.73
|
|
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B
Observation Period Week 13
|
-7.2 picogram per milliliter (pg/mL)
Standard Deviation 20.77
|
Adverse Events
Atrasentan
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atrasentan
n=20 participants at risk
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
OSTEOMYELITIS
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE RESPIRATORY FAILURE
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
10.0%
2/20 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Vascular disorders
AORTIC DISSECTION
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
Other adverse events
| Measure |
Atrasentan
n=20 participants at risk
Atrasentan 0.75 mg administered orally once daily (QD).
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC ANAEMIA
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Cardiac disorders
ANGINA PECTORIS
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Cardiac disorders
LEFT VENTRICULAR HYPERTROPHY
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Ear and labyrinth disorders
EUSTACHIAN TUBE DYSFUNCTION
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
DIARRHOEA
|
10.0%
2/20 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
GASTRITIS
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
NAUSEA
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
TOOTH DISORDER
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
VOMITING
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
OEDEMA PERIPHERAL
|
20.0%
4/20 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
BRONCHITIS
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
LOCALISED INFECTION
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
NASOPHARYNGITIS
|
20.0%
4/20 • Number of events 5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
PNEUMONIA
|
5.0%
1/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
TINEA CRURIS
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
TOOTH INFECTION
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
CHEST INJURY
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL INFLAMMATION
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
BLOOD CREATININE INCREASED
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
WEIGHT INCREASED
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
HEADACHE
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
DELIRIUM TREMENS
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
DEPRESSION
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
PANIC ATTACK
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Renal and urinary disorders
HAEMATURIA
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Renal and urinary disorders
POLLAKIURIA
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Social circumstances
DENTAL PROSTHESIS USER
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Vascular disorders
AORTIC ANEURYSM
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Vascular disorders
HAEMATOMA
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Vascular disorders
HYPERTENSION
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Vascular disorders
ORTHOSTATIC HYPERTENSION
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of atrasentan is administered until 30 days have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER