Trial Outcomes & Findings for A Study to Assess Sorafenib Alone and in Combination With Low-Dose Interferon Following Unsuccessful Treatment With Sunitinib in Patients With Advanced Renal Cell Cancer. (NCT NCT00678288)
NCT ID: NCT00678288
Last Updated: 2014-12-11
Results Overview
Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors \[RECIST\]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
From start of treatment of the first subject until 14 months later, assessed every 8 weeks
Results posted on
2014-12-11
Participant Flow
This study was conducted from 16 Apr 2008 to 26 Jun 2009 at 31 centers in 7 countries: France (11), Italy (6), Spain (5), Poland (4), Ireland (2), United Kingdom (2), and Austria (1). The planned enrollment was 120 subjects in the 2 treatment groups (60 subjects per group). The study was stopped early because of slow accrual.
A total of 24 subjects were screened; 16 were enrolled and randomized; 10 (63%) to sorafenib alone and 6 (37%) to sorafenib + interferon. All 16 randomized subjects received at least 1 dose of study drug and were included in the safety analysis population.
Participant milestones
| Measure |
Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
|
Sorafenib (Nexavar, BAY43-9006) + Interferon
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
| Measure |
Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
|
Sorafenib (Nexavar, BAY43-9006) + Interferon
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Study terminated by the sponsor
|
2
|
0
|
|
Overall Study
Not compliant with study medication
|
0
|
1
|
|
Overall Study
Switch to commercial drug
|
0
|
1
|
|
Overall Study
Reason not reported
|
1
|
0
|
|
Overall Study
Disease progression/recurrence/relapse
|
6
|
1
|
Baseline Characteristics
A Study to Assess Sorafenib Alone and in Combination With Low-Dose Interferon Following Unsuccessful Treatment With Sunitinib in Patients With Advanced Renal Cell Cancer.
Baseline characteristics by cohort
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=10 Participants
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
|
Sorafenib (Nexavar, BAY43-9006) + Interferon
n=6 Participants
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
60.5 years
n=7 Participants
|
58.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Memorial Sloane Kettering Cancer Center (MSKCC) score
low MSKCC score
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Memorial Sloane Kettering Cancer Center (MSKCC) score
intermediate MSKCC score
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment of the first subject until 14 months later, assessed every 8 weeksPopulation: Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.
Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors \[RECIST\]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment of the first subject until 14 months later, assessed every 8 WeeksPopulation: Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.
Response Rate was the best tumor response (confirmed Complete Response \[CR\], Partial Response \[PR\] or Stable Disease \[SD\]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment of the first subject until 14 months later, assessed every 8 WeeksPopulation: Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.
Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment of the first subject until 14 months later, assessed every 8 WeeksPopulation: Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.
Duration of Response was the time from date of first response (Complete Response \[CR\] or Partial Response \[PR\]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment of the first subject until 14 months later, assessed every 8 WeeksPopulation: Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.
Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Outcome measures
Outcome data not reported
Adverse Events
Sorafenib (Nexavar, BAY43-9006)
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Sorafenib (Nexavar, BAY43-9006) + Interferon
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=10 participants at risk
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
|
Sorafenib (Nexavar, BAY43-9006) + Interferon
n=6 participants at risk
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
|
|---|---|---|
|
General disorders
Fatigue
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
33.3%
2/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Infections and infestations
Infection (documented clinically), bronchus
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Pain, bone
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Pain, back
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
Other adverse events
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=10 participants at risk
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
|
Sorafenib (Nexavar, BAY43-9006) + Interferon
n=6 participants at risk
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
|
|---|---|---|
|
Immune system disorders
Rhinitis
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Blood and lymphatic system disorders
Neutrophils
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Blood and lymphatic system disorders
Hemoglobin
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Blood and lymphatic system disorders
Platelets
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
33.3%
2/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Blood and lymphatic system disorders
Leukocytes
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Cardiac disorders
Hypertension
|
20.0%
2/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Fatigue
|
70.0%
7/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
50.0%
3/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Weight loss
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Gastrointestinal disorders
Anorexia
|
20.0%
2/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
33.3%
2/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
5/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
50.0%
3/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Gastrointestinal disorders
Mucositis (functional/symptomatic), esophagus
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Gastrointestinal disorders
Mucositis (functional/symptomatic), oral cavity
|
20.0%
2/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Gastrointestinal disorders
Mucositis (functional/symptomatic), pharynx
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
50.0%
3/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Gastrointestinal disorders
Taste alteration
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
33.3%
2/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Infections and infestations
Infection (documented clinically), bronchus
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Infections and infestations
Infection (documented clinically), dental-tooth
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Skin and subcutaneous tissue disorders
Dermal change
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Musculoskeletal and connective tissue disorders
Extremity-upper (function)
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Metabolism and nutrition disorders
Metabolic/lab - other
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Nervous system disorders
Mood alteration, depression
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Nervous system disorders
Neuropathy: sensory
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Pain, back
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Pain, chest/thorax NOS
|
20.0%
2/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Pain, chest wall
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Pain, abdomen NOS
|
40.0%
4/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Pain, head/headache
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Pain, joint
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Pain, bone
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
20.0%
2/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
33.3%
2/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
2/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
50.0%
5/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Skin and subcutaneous tissue disorders
Dermatology - other
|
20.0%
2/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
50.0%
5/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
50.0%
3/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Skin and subcutaneous tissue disorders
Flushing
|
20.0%
2/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Reproductive system and breast disorders
Libido
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
10.0%
1/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
0.00%
0/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Ear and labyrinth disorders
Auditory/ear - ohter
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Fever
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
33.3%
2/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Insomnia
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Constitutional symptoms - other
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Vascular disorders
Hematoma
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Vascular disorders
Hemorrhage pulmonary, nose
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Infections and infestations
Infection (documented clinically), bladder (urinary)
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Infections and infestations
Infection (documented clinically), mucosa
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Metabolism and nutrition disorders
ALT
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Metabolism and nutrition disorders
AST
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
33.3%
2/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
50.0%
3/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
General disorders
Pain, muscle
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
16.7%
1/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/10
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
33.3%
2/6
Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Protocol and PI clinical trial agreements.
- Publication restrictions are in place
Restriction type: OTHER