Trial Outcomes & Findings for Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer (NCT NCT02010567)
NCT ID: NCT02010567
Last Updated: 2020-11-03
Results Overview
The MTD is the highest dose of CRLX101 at which ≤1 out of 6 patients had a dose limiting toxicity (DLT) using CTCAE v4.0 toxicity criteria. DLTs include Grade (G) \>3 neutropenia for ≥7 days; G 3 or 4 neutropenia with fever; G 4 anemia not related to cancer-associated bleeding; G 4 thrombocytopenia or G 3 with clinically significant bleeding; G ≥3 nausea or vomiting \>48 hours despite anti-emetics; G 2 cystitis not resolved within 14 days; second G 2 cystitis; G 3 or 4 cystitis; diarrhea requiring dose reduction; Any other non-hematologic toxicity G ≥3 requiring a dose reduction (G ≥3 infusion-related reactions were not a DLT unless they recur despite slowing down the infusion); Other CRLX101 related treatment emergent adverse effect (TEAE) that requires patient withdrawal prior to completing all doses; Radiotherapy interruption due to TEAEs ≥5 days; or Dose interruption or reduction of capecitabine due to TEAE that results in \<50% of the scheduled capecitabine dose for entire course
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-11-03
Participant Flow
Patients were recruited from 5 medical institutions between December 2013 and September 2016
A total of 39 patients were consented to this study; 4 patients were found ineligible, 3 withdrew prior to treatment, leaving 32 patients who went on study.
Participant milestones
| Measure |
Cohort A, Phase Ib, Dose Level 1
CRLX101 12mg/ m\^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks
|
Cohort A, Phase Ib, Dose Level 2
CRLX101 15mg/ m\^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks
|
Cohort A, Phase II, Dose Level 2
CRLX101 15mg/ m\^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks
|
Cohort B, Phase Ib, Dose Level 1, Weekly
CRLX101 12mg/ m\^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks
|
Cohort B, Phase Ib, Dose Level 2, Weekly
CRLX101 15mg/ m\^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
14
|
3
|
6
|
|
Overall Study
COMPLETED
|
3
|
6
|
13
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort A, Phase Ib, Dose Level 1
CRLX101 12mg/ m\^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks
|
Cohort A, Phase Ib, Dose Level 2
CRLX101 15mg/ m\^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks
|
Cohort A, Phase II, Dose Level 2
CRLX101 15mg/ m\^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks
|
Cohort B, Phase Ib, Dose Level 1, Weekly
CRLX101 12mg/ m\^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks
|
Cohort B, Phase Ib, Dose Level 2, Weekly
CRLX101 15mg/ m\^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer
Baseline characteristics by cohort
| Measure |
Cohort A, Phase Ib, Dose Level 1
n=3 Participants
CRLX101 12mg/ m\^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 by mouth two times a day (PO BID), Monday through Friday (M-F) XRT 180 centigray (cGy)/day, M-F for 6 weeks
|
Cohort A, Phase Ib, Dose Level 2
n=6 Participants
CRLX101 15mg/ m\^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks
|
Cohort A, Phase II, Dose Level 2
n=14 Participants
CRLX101 15mg/ m\^2 , via intravenous catheter (IV), on Monday, every other week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks
|
Cohort B, Phase Ib, Dose Level 1, Weekly
n=3 Participants
CRLX101 12mg/ m\^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks
|
Cohort B, Phase Ib, Dose Level 2, Weekly
n=6 Participants
CRLX101 15mg/ m\^2 , via intravenous catheter (IV), on Monday, every week for the first five weeks of chemoradiation.
Capecitabine 825mg/ m\^2 PO BID, M-F XRT 180 cGy/day, M-F for 6 weeks
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Since this objective applies only to Phase Ib patients, the Phase II cohort patients were not included
The MTD is the highest dose of CRLX101 at which ≤1 out of 6 patients had a dose limiting toxicity (DLT) using CTCAE v4.0 toxicity criteria. DLTs include Grade (G) \>3 neutropenia for ≥7 days; G 3 or 4 neutropenia with fever; G 4 anemia not related to cancer-associated bleeding; G 4 thrombocytopenia or G 3 with clinically significant bleeding; G ≥3 nausea or vomiting \>48 hours despite anti-emetics; G 2 cystitis not resolved within 14 days; second G 2 cystitis; G 3 or 4 cystitis; diarrhea requiring dose reduction; Any other non-hematologic toxicity G ≥3 requiring a dose reduction (G ≥3 infusion-related reactions were not a DLT unless they recur despite slowing down the infusion); Other CRLX101 related treatment emergent adverse effect (TEAE) that requires patient withdrawal prior to completing all doses; Radiotherapy interruption due to TEAEs ≥5 days; or Dose interruption or reduction of capecitabine due to TEAE that results in \<50% of the scheduled capecitabine dose for entire course
Outcome measures
| Measure |
Dose Escalation Phase Ib
n=18 Participants
Phase Ib patients who received at least one dose of CRLX101 at either 12mg/m2 or 15mg/m2 either every other week (Cohort A) or weekly (Cohort B)
|
|---|---|
|
Maximum Tolerated Dose (MTD) of CRLX101 When Added to Standard Neoadjuvant Chemoradiotherapy Consisting of Capecitabine + Radiotherapy in Locally Advanced Rectal Cancer
|
15 mg/m^2 every other week
|
PRIMARY outcome
Timeframe: 12 weeksPrimary Objective Phase II: Pathological response will be made based on microscopic assessment of the surgical specimen at the primary treatment site. A pCR must include no gross or microscopic tumor identified anywhere within the surgical specimen. This must include:No evidence of malignant cells in the primary tumor specimen and No lymph nodes that contain tumor.
Outcome measures
| Measure |
Dose Escalation Phase Ib
n=32 Participants
Phase Ib patients who received at least one dose of CRLX101 at either 12mg/m2 or 15mg/m2 either every other week (Cohort A) or weekly (Cohort B)
|
|---|---|
|
Pathological Complete Response (pCR) Rate
|
19 percentage of participants with pCR
Interval 7.0 to 36.0
|
SECONDARY outcome
Timeframe: 12 weeksPathologic response will be made based on microscopic assessment of the surgical specimen at the primary treatment site, including regional nodes and any peritumoral satellite nodules in the specimen, and categorized as outlined below as per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 7th edition.Determination of pathological response will be reported by the local pathologist. * Pathologic Complete Response (pCR): No gross or microscopic tumor identified anywhere within the surgical specimen. This must include: No evidence of malignant cells in the primary tumor specimen and No lymph nodes that contain tumor. * Moderate response: Single cells or small groups of cancer cells * Minimal response: Residual cancer outgrown by fibrosis * Poor response:Minimal or no tumor kill; extensive residual cancer
Outcome measures
| Measure |
Dose Escalation Phase Ib
n=32 Participants
Phase Ib patients who received at least one dose of CRLX101 at either 12mg/m2 or 15mg/m2 either every other week (Cohort A) or weekly (Cohort B)
|
|---|---|
|
Pathological Response Rate
pCR
|
6 Participants
|
|
Pathological Response Rate
Moderate response
|
18 Participants
|
|
Pathological Response Rate
Minimal response
|
7 Participants
|
|
Pathological Response Rate
Unknown
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksToxicity profile of CRLX101 when combined with capecitabine + radiotherapy to treat patients with locally advanced rectal cancer. Phase Ib and Phase II - Safety is the reported adverse event (AE) profile characterized by NCI CTCAE v4.0. The profile was limited to grade 3 or higher, treatment related AEs.
Outcome measures
| Measure |
Dose Escalation Phase Ib
n=32 Participants
Phase Ib patients who received at least one dose of CRLX101 at either 12mg/m2 or 15mg/m2 either every other week (Cohort A) or weekly (Cohort B)
|
|---|---|
|
Number of Participants With Grade 3 or Higher, Treatment-related Toxicities
Colitis
|
1 participants with AE
|
|
Number of Participants With Grade 3 or Higher, Treatment-related Toxicities
Dermatitis, radiation
|
1 participants with AE
|
|
Number of Participants With Grade 3 or Higher, Treatment-related Toxicities
Diarrhea
|
1 participants with AE
|
|
Number of Participants With Grade 3 or Higher, Treatment-related Toxicities
Hypophosphatemia
|
1 participants with AE
|
|
Number of Participants With Grade 3 or Higher, Treatment-related Toxicities
Lymphocyte count decreased
|
9 participants with AE
|
|
Number of Participants With Grade 3 or Higher, Treatment-related Toxicities
Rectal obstruction
|
1 participants with AE
|
|
Number of Participants With Grade 3 or Higher, Treatment-related Toxicities
White blood cell decreased
|
1 participants with AE
|
SECONDARY outcome
Timeframe: An average of 2.6 years (full range 2.1 to 3.1 years)Population: 14 of 32 participants were enrolled in the Phase II portion of the study. Of these 14, one participant withdrew prior to surgery and was therefore not evaluable for this outcome
Phase II only - DFS will be defined as the time from surgical resection until disease recurrence or death as a result of any cause, reported as the count of participants still alive without recurrence at the end of study follow-up.
Outcome measures
| Measure |
Dose Escalation Phase Ib
n=13 Participants
Phase Ib patients who received at least one dose of CRLX101 at either 12mg/m2 or 15mg/m2 either every other week (Cohort A) or weekly (Cohort B)
|
|---|---|
|
Disease-free Survival (DFS) Rate
|
10 Participants
|
SECONDARY outcome
Timeframe: an average of 2.6 years (full range 2.1 to 3.1 years)Population: 14 of 32 participants were enrolled in the Phase II portion of the study. Of these 14, one participant withdrew prior to surgery and was therefore not evaluable for this outcome
Phase II only - OS is defined as the time from surgical resection until death reported as the count of participants still alive at the end of study follow-up.
Outcome measures
| Measure |
Dose Escalation Phase Ib
n=13 Participants
Phase Ib patients who received at least one dose of CRLX101 at either 12mg/m2 or 15mg/m2 either every other week (Cohort A) or weekly (Cohort B)
|
|---|---|
|
Overall Survival (OS) Rate
|
13 Participants
|
SECONDARY outcome
Timeframe: an average of 2.6 years (full range 2.1 to 3.1 years)Population: 14 of 32 participants were enrolled in the Phase II portion of the study. Of these 14, one participant withdrew prior to surgery and was therefore not evaluable for this outcome
Phase II only - a comparison of DFS for patients who achieve pCR and those who do not. DFS will be defined as the time from surgical resection until disease recurrence or death as a result of any cause, reported as the count of participants still alive without recurrence at the end of study follow-up.
Outcome measures
| Measure |
Dose Escalation Phase Ib
n=13 Participants
Phase Ib patients who received at least one dose of CRLX101 at either 12mg/m2 or 15mg/m2 either every other week (Cohort A) or weekly (Cohort B)
|
|---|---|
|
Disease-free Survival (DFS) Rate Based on Pathological Complete Response (pCR).
pathological complete response (pCR)
|
2 Participants
|
|
Disease-free Survival (DFS) Rate Based on Pathological Complete Response (pCR).
Did not achieve pCR
|
8 Participants
|
SECONDARY outcome
Timeframe: an average of 2.6 years (full range 2.1 to 3.1 years)Population: 14 of 32 participants were enrolled in the Phase II portion of the study. Of these 14, one participant withdrew prior to surgery and was therefore not evaluable for this outcome
Phase II only - a comparison of OS for patients who achieve pCR and those who do not. OS is defined as the time from surgical resection until death reported as the count of participants still alive at the end of study follow-up.
Outcome measures
| Measure |
Dose Escalation Phase Ib
n=13 Participants
Phase Ib patients who received at least one dose of CRLX101 at either 12mg/m2 or 15mg/m2 either every other week (Cohort A) or weekly (Cohort B)
|
|---|---|
|
Overall Survival (OS) Based on Pathological Complete Response (pCR).
pathological complete response (pCR)
|
2 Participants
|
|
Overall Survival (OS) Based on Pathological Complete Response (pCR).
Did not achieve pCR
|
11 Participants
|
Adverse Events
Cohort A, Phase Ib, Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort A, Phase Ib, Level 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort A, Phase II, Level 2
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort B, Phase Ib, Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B, Phase Ib, Level 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A, Phase Ib, Level 1
n=3 participants at risk
12mg/m\^2 CRLX101 every other week + 825mg/m\^2 BID Capecitabine + XRT
|
Cohort A, Phase Ib, Level 2
n=6 participants at risk
15mg/m\^2 CRLX101 every other week + 825mg/m\^2 BID Capecitabine + XRT
|
Cohort A, Phase II, Level 2
n=14 participants at risk
15mg/m\^2 CRLX101 IV weekly + 825mg/m\^2 BID Capecitabine + XRT
|
Cohort B, Phase Ib, Level 1
n=3 participants at risk
12mg/m\^2 CRLX101 IV weekly + 825mg/m\^2 BID Capecitabine + XRT
|
Cohort B, Phase Ib, Level 2
n=6 participants at risk
15mg/m\^2 CRLX101 IV weekly + 825mg/m\^2 BID Capecitabine + XRT
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
Other adverse events
| Measure |
Cohort A, Phase Ib, Level 1
n=3 participants at risk
12mg/m\^2 CRLX101 every other week + 825mg/m\^2 BID Capecitabine + XRT
|
Cohort A, Phase Ib, Level 2
n=6 participants at risk
15mg/m\^2 CRLX101 every other week + 825mg/m\^2 BID Capecitabine + XRT
|
Cohort A, Phase II, Level 2
n=14 participants at risk
15mg/m\^2 CRLX101 IV weekly + 825mg/m\^2 BID Capecitabine + XRT
|
Cohort B, Phase Ib, Level 1
n=3 participants at risk
12mg/m\^2 CRLX101 IV weekly + 825mg/m\^2 BID Capecitabine + XRT
|
Cohort B, Phase Ib, Level 2
n=6 participants at risk
15mg/m\^2 CRLX101 IV weekly + 825mg/m\^2 BID Capecitabine + XRT
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
4/6 • Number of events 4 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
14.3%
2/14 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
50.0%
3/6 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
4/6 • Number of events 4 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
78.6%
11/14 • Number of events 11 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
4/6 • Number of events 4 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
28.6%
4/14 • Number of events 4 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
14.3%
2/14 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
21.4%
3/14 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Investigations
Cholesterol high
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
4/6 • Number of events 4 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
28.6%
4/14 • Number of events 4 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
100.0%
3/3 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
28.6%
4/14 • Number of events 4 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
4/6 • Number of events 4 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
71.4%
10/14 • Number of events 10 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
83.3%
5/6 • Number of events 5 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
50.0%
3/6 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
78.6%
11/14 • Number of events 11 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
83.3%
5/6 • Number of events 5 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Hemorrhoids
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
4/6 • Number of events 4 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
35.7%
5/14 • Number of events 5 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
35.7%
5/14 • Number of events 5 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
50.0%
3/6 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
28.6%
4/14 • Number of events 4 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
21.4%
3/14 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
21.4%
3/14 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
100.0%
3/3 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
14.3%
2/14 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
14.3%
2/14 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
4/6 • Number of events 4 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
28.6%
4/14 • Number of events 4 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
100.0%
3/3 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
50.0%
3/6 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
50.0%
3/6 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
57.1%
8/14 • Number of events 8 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
4/6 • Number of events 4 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
50.0%
3/6 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
35.7%
5/14 • Number of events 5 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
14.3%
2/14 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
50.0%
3/6 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
14.3%
2/14 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
50.0%
3/6 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
21.4%
3/14 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
35.7%
5/14 • Number of events 5 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Rectal mucositis
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Rectal obstruction
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Rectal pain
|
100.0%
3/3 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
50.0%
3/6 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
28.6%
4/14 • Number of events 4 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
100.0%
3/3 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
50.0%
3/6 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
35.7%
5/14 • Number of events 5 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Renal and urinary disorders
Urinary tract pain
|
100.0%
3/3 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Renal and urinary disorders
Urinary urgency
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
14.3%
2/14 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/14 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/6 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
0.00%
0/3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
|
Investigations
White blood cell decreased
|
100.0%
3/3 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
35.7%
5/14 • Number of events 5 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
50.0%
3/6 • Number of events 3 • Adverse events were collected up to 30 days after treatment was discontinued (approximately 12 weeks from study entry)
All patients were evaluated for serious adverse events (SAEs)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place