Trial Outcomes & Findings for SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC (NCT NCT00440271)
NCT ID: NCT00440271
Last Updated: 2014-06-27
Results Overview
percentage of participants whose viral load \<50 copies/mL at Week 48
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
33 participants
Primary outcome timeframe
after 48 weeks of treatment
Results posted on
2014-06-27
Participant Flow
Participant milestones
| Measure |
Standard of Care (SoC)
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
|
Therapeutic Drug Monitoring (TDM)
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
18
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
Standard of Care (SoC)
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
|
Therapeutic Drug Monitoring (TDM)
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Due to closure of trial
|
8
|
10
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC
Baseline characteristics by cohort
| Measure |
Standard of Care (SoC)
n=15 Participants
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
|
Therapeutic Drug Monitoring (TDM)
n=18 Participants
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 8.2 • n=99 Participants
|
43.2 years
STANDARD_DEVIATION 10.6 • n=107 Participants
|
44.5 years
STANDARD_DEVIATION 9.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: after 48 weeks of treatmentPopulation: The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
percentage of participants whose viral load \<50 copies/mL at Week 48
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)Population: The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)Population: The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)Population: The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)Population: The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after Day 1 of treatmentPopulation: The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL \>50 copies/mL at two consecutive measurements after having achieved a VL \<50 copies/mL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after Day 1 of treatmentPopulation: The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)Population: The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)Population: The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)Population: The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 4 weeks of treatmentPopulation: The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)Population: The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)Population: The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4Outcome measures
Outcome data not reported
Adverse Events
Standard of Care (SoC)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Therapeutic Drug Monitoring (TDM)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care (SoC)
n=15 participants at risk
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
|
Therapeutic Drug Monitoring (TDM)
n=18 participants at risk
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Eye disorders
Eye discharge
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Gastrointestinal disorders
Colonic polyp
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
5/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
16.7%
3/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
22.2%
4/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
General disorders
Adverse drug reaction
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
General disorders
Fatigue
|
20.0%
3/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
General disorders
Feeling abnormal
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
General disorders
Pyrexia
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Infections and infestations
Conjunctivitis infective
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Infections and infestations
Genital herpes
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Infections and infestations
Infection
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Infections and infestations
Oral candidiasis
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Infections and infestations
Rash pustular
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Investigations
Blood amylase increased
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Investigations
Blood cholesterol increased
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Investigations
Blood triglycerides increased
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
11.1%
2/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Investigations
Lipase increased
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
13.3%
2/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.3%
2/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
11.1%
2/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Psychiatric disorders
Nightmare
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
2/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
5.6%
1/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Vascular disorders
Hot flush
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
0.00%
0/18 • 48 weeks of treatment plus 30 days follow-up
MedDra 11.1 WHO-DD 08SEP
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract
- Publication restrictions are in place
Restriction type: OTHER